(162 days)
No
The summary describes a physical implantable device and its clinical performance, with no mention of AI/ML components or functions. The MRI review was performed by human radiologists.
Yes
The device is intended for implantation to reinforce soft tissue for the repair of anal and rectal fistulas, and it is designed to inhibit the movement of enteric matter and provide a scaffold for tissue ingrowth to close the fistula, which attributes a therapeutic function to the device by actively participating in the healing process.
No
The device is described as an implanted system for the repair and closure of anal and rectal fistulas, serving as a scaffold for tissue ingrowth rather than for diagnosis. While MRIs are used to assess the success of the treatment, the device itself is therapeutic, not diagnostic.
No
The device description explicitly lists physical components (Sealing Disk, Sheath, Dilator, Collagen Matrices, resorbable sutures) and describes it as a "medical device consisting of" these items, indicating it is a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "implantation to reinforce soft tissue for the repair of anal and rectal fistulas." This describes a surgical device used directly on the patient's body for treatment.
- Device Description: The device consists of physical components like a Sealing Disk, Sheath, Dilator, Collagen Matrices, and sutures. These are all materials designed for physical implantation and structural support.
- Mechanism of Action: The device is designed to "inhibit the movement of enteric matter into the anorectal fistula tract and to provide a scaffold for tissue ingrowth." This is a mechanical and biological process occurring within the patient's body, not an in vitro test.
- Lack of In Vitro Testing: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to diagnose or monitor a condition. The performance studies focus on clinical outcomes in patients.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic implant used directly in the body.
N/A
Intended Use / Indications for Use
The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF™) is for implantation to reinforce soft tissue for the repair of anal and rectal fistulas.
Product codes
FTM
Device Description
The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF") is a medical device consisting of a Sealing Disk, Sheath, Dilator, Collagen Matrices and resorbable sutures. The PICS-AF Closure System is designed as a sphincter-sparing device that inhibits the movement of enteric matter into the anorectal fistula tract and to provide a scaffold for tissue ingrowth to occur to close the anorectal fistula.
The PICS-AF Closure System is a sterile, single-use medical device that is designed to be implanted, using a minimally invasive surgical technique, to reinforce soft tissue for the repair of anal and rectal fistulas like the predicate devices. As the PICS-AF Closure System is specifically designed to be sphincter sparing, it does not preclude performing a repeat PICS-AF procedure or any other fistula repair procedure, if required. The key features of the CuraSeal PICS-AF Closure System include the Sealing Disk, Sheath, Dilator, Collagen Matrices and resorbable sutures. There are two models of the PICS-AF device (M1 and M2). Model M1 has a smaller Sealing Disk and smaller diameter Collagen Matrices than Model M2. The Collagen Matrices consist of up to six collagen dowels that are implanted in the fistula tract. After placement, any excess collagen dowels are removed or trimmed at the time of surgery. Placement of the PICS-AF device to cover the inner ostium opening of the fistula tract inhibits the movement of enteric matter into the fistula tract and the collagen provides a scaffold for wound healing to occur to close the anorectal fistula. The Collagen Matrices are delivered directly into the fistula tract and are secured to the fistula tract or the surrounding tissue by resorbable sutures. The Collagen Matrices are resorbed by the body during the natural healing process. The silicone Sealing Disk is designed to be expelled from the body as waste once the resorbable sutures have resorbed. Alternatively, the silicone Sealing Disk can be removed by the physician during the first two months following the procedure if the Sealing Disk appears in the patient's anal canal or causes any discomfort. Similar to the predicate devices, the external fistula opening (EFO) is left open during the healing process to allow for drainage to prevent infection or abscess formation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anal and rectal fistulas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
A prospective, non-randomized clinical study was conducted to evaluate the safety and effectiveness of the PICS-AF Closure System for repair of anorectal fistulas. The PICS-AF Closure System was used in 30 subjects enrolled in the study from one clinical site in Europe. Eight different investigators treated the 30 PICS-AF subjects. The primary effectiveness endpoint for this study was fistula closure success at 6 months defined as complete healing of the fistula tract and associated external opening without drainage or abscess. Fistula closure success for the PICS-AF device was assessed using MRIs from Month 6. The MRI results were reviewed and adjudicated by three independent U.S. radiologists. The rate of the PICS-AF closure success at 6 months was 46.67% (14/30) based on the Intent-to-Treat (ITT) population results and 66.67% (14/21) based on the Per Protocol (PP) population results. The primary safety endpoint for this study was the proportion of subjects experiencing a serious adverse event (i.e., an infection, enlargement of the fistula, an allergic reaction to the PICS-AF device, etc.) through 6 months of post-procedure follow-up. There were three subjects who experienced a Serious Adverse Event during this study (two subjects had a fistula abscess and the third subject had a seton placed). The PICS-AF safety results have demonstrated that the overall primary safety endpoint was met.
Key Metrics
Fistula closure success rate (ITT population) at 6 months: 46.67% (14/30)
Fistula closure success rate (PP population) at 6 months: 66.67% (14/21)
Overall PICS-AF adverse event data: 50%
Primary Safety Endpoint (Serious Adverse Event): 10.00% (3/30)
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2017
CuraSeal, Inc. % Mr. Kit Cariquitan Experien Group, LLC 755 North Mathilda Ave Sunnyvale, CA 94085
Re: K162388
Trade/Device Name: CuraSeal PICS Fistulae Closure Device -PICS - AF - M1™ PICS -AF - M2"M Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTM Dated: December 16, 2016 Received: December 19, 2016
Dear Mr. Cariquitan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Binita S. Ashar -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AFTM)
Indications for Use (Describe)
The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AFTM) is for implantation to reinforce soft tissue for the repair of anal and rectal fistulas.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
CONSTITUTION OF THE FOR FOR FOR FOR FOR FDA USE ONLY CONTRACTOR CONSULTION OF
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
510(k) Notification K
K162388, pg. 1 of 11
GENERAL INFORMATION [807.92(a)(1)]
Applicant:
CuraSeal, Inc. 2231 Calle de Luna Santa Clara, CA 95054 USA Phone: 408-565-8787 Fax: 408-986-8643
Contact Person:
Kit Cariquitan Chief Regulatory Officer Experien Group, LLC 755 N. Mathilda Ave, Suite 100 Sunnyvale, CA 94085 USA Phone: 408-400-0856 Fax: 408-400-0865
Date Prepared: August 12, 2016
DEVICE INFORMATION [807.92(a)(2)]
The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF") is a medical device consisting of a Sealing Disk, Sheath, Dilator, Collagen Matrices and resorbable sutures. The PICS-AF Closure System is designed as a sphincter-sparing device that inhibits the movement of enteric matter into the anorectal fistula tract and to provide a scaffold for tissue ingrowth to occur to close the anorectal fistula.
Trade Name:
CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF")
Generic/Common Name: Surgical Mesh
Classification: 21 CFR§878.3300, Class II
Product Code: FTM
4
PREDICATE DEVICE(S) [807.92(a)(3)]
K162388, pg. 2 of 11
- W.L. Gore & Associates, GORE BIO-A Fistula Plug (K083266)
- . Cook Biotech, SIS Fistula Plug (K050337)
The Cook Biotech, SURGISIS® RVP™ Recto-Vaginal Fistula Plug (K062729) is added as a reference device due to its same intended use and similar technological characteristics.
The predicate devices have not been subject to a design-related recall.
DEVICE DESCRIPTION [807.92(a)(4)]
The PICS-AF Closure System is a sterile, single-use medical device that is designed to be implanted, using a minimally invasive surgical technique, to reinforce soft tissue for the repair of anal and rectal fistulas like the predicate devices. As the PICS-AF Closure System is specifically designed to be sphincter sparing, it does not preclude performing a repeat PICS-AF procedure or any other fistula repair procedure, if required. The key features of the CuraSeal PICS-AF Closure System include the Sealing Disk, Sheath, Dilator, Collagen Matrices and resorbable sutures. There are two models of the PICS-AF device (M1 and M2). Model M1 has a smaller Sealing Disk and smaller diameter Collagen Matrices than Model M2. The Collagen Matrices consist of up to six collagen dowels that are implanted in the fistula tract. After placement, any excess collagen dowels are removed or trimmed at the time of surgery. Placement of the PICS-AF device to cover the inner ostium opening of the fistula tract inhibits the movement of enteric matter into the fistula tract and the collagen provides a scaffold for wound healing to occur to close the anorectal fistula. The Collagen Matrices are delivered directly into the fistula tract and are secured to the fistula tract or the surrounding tissue by resorbable sutures. The Collagen Matrices are resorbed by the body during the natural healing process. The silicone Sealing Disk is designed to be expelled from the body as waste once the resorbable sutures have resorbed. Alternatively, the silicone Sealing Disk can be removed by the physician during the first two months following the procedure if the Sealing Disk appears in the patient's anal canal or causes any discomfort. Similar to the predicate devices, the external fistula opening (EFO) is left open during the healing process to allow for drainage to prevent infection or abscess formation.
INDICATIONS FOR USE [807.92(a)(5)]
The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF") is for implantation to reinforce soft tissue for the repair of anal and rectal fistulas.
TECHNOLOGICAL CHARACTERISTICS [807.92(a)(6)]
The technological characteristics of the CuraSeal PICS-AF Closure System are similar and substantially equivalent to the predicate devices. Table 1 lists the technological characteristics of the PICS-AF device and the predicate devices. Table 1 also provides the rationale to support a determination of substantial equivalence. Any differences between the devices do not raise different questions of safety or effectiveness. Performance data, including clinical testing, were provided to support the determination
5
of substantial equivalence. Clinical testing was performed by CuraSeal. The results from the clinical testing support the safe and effective use of the PICS-AF Closure System for anal and rectal fistula repair and further establish the substantial equivalence to the predicate devices.
| Feature | CuraSeal
PICS-AF | W.L. Gore &
Associates,
GORE BIO-A
Fistula Plug
(Predicate) | Cook Biotech,
SIS Fistula Plug
(Predicate) | Cook Biotech,
Modified SIS
Fistula Plug
(Reference) | Substantial
Equivalence
Rationale |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | TBD | K083266 | K050337 | K062729 | -- |
| Indications
for Use | The CuraSeal
Percutaneous
Intraluminal
Closure System
for Anorectal
Fistulas
(PICS-AF™) is
for implantation
to reinforce soft
tissue for the
repair of anal
and rectal
fistulas. | The GORE
BIO-A™
Fistula Plug
device is
intended for
use in the
reinforcement
of soft tissue
for the repair of
anorectal
fistulas. | The SIS Fistula
Plug is for
implantation to
reinforce soft
tissue where a
rolled
configuration is
required, for
repair of anal,
rectal, and
enterocutaneous
fistulas. The
device is
supplied sterile
and is intended
for one-time use. | The Modified
SIS Fistula Plug
is for
implantation to
reinforce soft
tissue for repair
of recto-vaginal
fistulas. The
device is
supplied sterile
and is intended
for one-time
use. | Like the predicate
devices, the
PICS-AF device
reinforces soft
tissue for the repair
of anal and rectal
fistulas. It is also
supplied sterile and
is intended for
one-time use. The
minor differences in
the indications for
use statements do
not affect the safety
and effectiveness of
the PICS-AF
device. |
| Classification/
Product Code | §878.3300
FTM | §878.3300
FTL | §878.3300
FTM | §878.3300
FTM | Same classification.
Same or similar
Product Code |
| Anatomical
Location | Anal and rectal
fistulas | Anal and rectal
fistulas | Anal, rectal, or
enterocutaneous
fistulas | Rectal and
vaginal fistulas | Same or similar
anatomical location |
| Feature | CuraSeal
PICS-AF | W.L. Gore &
Associates,
GORE BIO-A
Fistula Plug
(Predicate) | Cook Biotech,
SIS Fistula Plug
(Predicate) | Cook Biotech,
Modified SIS
Fistula Plug
(Reference) | Substantial
Equivalence
Rationale |
| | Bovine dermis-
derived, cross-
linked collagen | Synthetic
PGA/TMC
copolymer | Porcine-derived
small intestine
submucosa | Porcine-derived
small intestine
submucosa | Like the predicate
devices, the
resorbable material
acts as a scaffold to
specifically
reinforce soft tissue
and promote
healing of the
fistula tract. Design
verification and
clinical testing
demonstrate that the
PICS-AF device is
safe and performs
as intended. The
PICS-AF is
substantially
equivalent to the
predicate devices. |
| Resorbable
Plug Shape | Round dowels,
segmented up to
6 dowels/device | One piece
device consists
of Cap and six
round hollow
tube segments.
Tube segments
are cut to
length and/or
cut off to suit
fistula
diameter. | Tapered rolled
sheet, one piece
cut to length | Tapered rolled
sheet, one piece
cut to length | All devices have
plugs that occupy
the fistula tract and
any excess material
is trimmed from the
device at the time
of surgery. The
PICS-AF is
substantially
equivalent to the
predicate devices. |
| Attachment
Mechanism | Internal disk and
resorbable
sutures | Internal cap
and resorbable
sutures | Resorbable
sutures | Internal disk
and resorbable
sutures | All devices have
similar attachment
mechanism. Design
verification and
clinical testing
demonstrate that the
PICS-AF device is
safe and performs
as intended. The
PICS-AF is
substantially
equivalent to the
predicate devices. |
| Feature | CuraSeal
PICS-AF | W.L. Gore &
Associates,
GORE BIO-A
Fistula Plug
(Predicate) | Cook Biotech,
SIS Fistula Plug
(Predicate) | Cook Biotech,
Modified SIS
Fistula Plug
(Reference) | Substantial
Equivalence
Rationale |
| Disk Design | Sealing Disk | Disk | N/A | Button/Flange | Like the GORE
BIO-A Fistula Plug,
the internal opening
of the ostium is
closed to mitigate
enteric fluids from
entering the fistula
tract. Design
verification and
clinical testing
demonstrate that the
PICS-AF device is
safe and performs
as intended. The
PICS-AF is
substantially
equivalent to the
predicate devices. |
| Delivery
Sheath Design | Protects
collagen and
keeps it clean
when pulled into
tract | N/A | N/A | N/A | Design verification
and clinical testing
demonstrate that the
addition of the
Sheath/Dilator for
the PICS-AF device
does not increase
the risk to the
patient and is
therefore
substantially
equivalent to the
predicate devices. |
| Sterilization
Method | Ethylene Oxide
Gas | Gamma
Irradiation | Ethylene Oxide
Gas | Ethylene Oxide
Gas | Same sterility
assurance level,
same or similar
sterilization method |
Table 1: Summary of Technological Characteristics
6
7
8
SUBSTANTIAL EQUIVALENCE
The indications for use for the CuraSeal PICS-AF Closure System is substantially equivalent to the indications for use of the predicate devices. Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, the CuraSeal PICS-AF Closure System is substantially equivalent to the predicate devices.
PERFORMANCE DATA [807.92(b)]
All necessary bench and clinical testing were conducted on the CuraSeal PICS-AF Closure System to support a determination of substantial equivalence to the predicate devices.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench and clinical testing were conducted on the CuraSeal PICS-AF Closure System to support a determination of substantial equivalence to the predicate devices.
Non-clinical Testing Summary [807.92(b)(1)]:
The non-clinical, bench testing included:
- . Design verification and bench validation studies, including dimensional analysis
- Physician simulated use
- Biocompatibility ●
- Sterilization ●
- Packaging and shelf-life
The collective results of the non-clinical testing demonstrate that the materials chosen, the manufacturing processes utilized and the design of the CuraSeal PICS-AF Closure System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrate that the CuraSeal PICS-AF Closure System does not raise different questions of safety or effectiveness for the repair of anorectal fistulas when compared to the predicate devices.
9
Clinical Testing Summary [807.92(b)(2)]:
A prospective, non-randomized clinical study was conducted to evaluate the safety and effectiveness of the PICS-AF Closure System for repair of anorectal fistulas. The safety and effectiveness rates for the PICS-AF devices were compared to historical control data generated from commercially available anorectal fistula repair devices.
The PICS-AF Closure System was used in 30 subjects enrolled in the study from one clinical site in Europe. Eight different investigators treated the 30 PICS-AF subjects. There were also 19 Historical Control subjects that were treated using a commercially available fistula plug (GORE BIO-A Fistula Plug) at this same clinical site and were evaluated as part of the PICS-AF clinical study.
The primary effectiveness endpoint for this study was fistula closure success at 6 months defined as complete healing of the fistula tract and associated external opening without drainage or abscess. Fistula closure success for the PICS-AF device was assessed using MRIs from Month 6. The MRI results were reviewed and adjudicated by three independent U.S. radiologists. The rate of the PICS-AF closure success at 6 months was 46.67% (14/30) based on the Intent-to-Treat (ITT) population results and 66.67% (14/21) based on the Per Protocol (PP) population results. Nine subjects had inclusion/exclusion deviations, based on the independent MRI assessment, and thus should have been disqualified from participating in the PICS-AF study.
The primary safety endpoint for this study was the proportion of subjects experiencing a serious adverse event (i.e., an infection, enlargement of the fistula, an allergic reaction to the PICS-AF device, etc.) through 6 months of post-procedure follow-up. There were three subjects who experienced a Serious Adverse Event during this study (two subjects had a fistula abscess and the third subject had a seton placed). The two subjects with a fistula abscess have recovered without sequelae and the subject with the seton is stable. The PICS-AF safety results have demonstrated that the overall primary safety endpoint was met. The PICS-AF safety data was comparable to the Historical Control group. The overall PICS-AF adverse event data was 50% as compared to 36.84% for the Historical Controls; however, this difference was not statistically significant (P=0.3955).
Table 2 provides the baseline demographics and characteristics for the control (GORE BIO-A Fistula Plug) and PICS-AF treatment groups.
| Characteristic | Control
N=19 | PICS-AF
N=30 | P-value |
|----------------------|-------------------|-------------------|---------|
| Gender: n/N (% Male) | 17/19 (89.47%) | 23/30 (76.67%) | 0.4511a |
| Age: Mean (SD) N | 50.11 (7.522) 18c | 53.70 (12.086) 30 | 0.2112b |
| Median (Min, Max) | 49.5 (35, 64) | 56.5 (31, 76) | |
| Smoker: n/N (%) | 5/19 (26.32%) | 11/30 (36.67%) | 0.5412a |
| Obese: n/N (%) | 4/19 (21.05%) | 7/30 (23.33%) | 1.0000a |
| Diabetes: n/N (%) | 5/19 (26.32%) | 2/30 (6.67%) | 0.0926a |
Table 2: Baseline Demographics and Characteristics
aTwo-sided Fisher's exact test.
bTwo-sided unequal variance t-test.
One Historical Control subject did not record age.
10
Table 3 provides a comparison of the fistula variables at baseline for the control (GORE BIO-A Fistula Plug) and PICS-AF treatment groups.
| Characteristic | Control
N=19 | PICS-AF
N=30 |
|---------------------------------------------------------|---------------------------|---------------------------|
| Onset of Fistula: Mean (Min, Max) | 32.6 mo. (5 mo., 121 mo.) | 57.2 mo. (4 mo., 246 mo.) |
| Type of Fistula: Transsphincteric | 19/19 (100%) | 30/30 (100%) |
| Length of Fistula Tract (cm):
Mean (SD) N | 4.1000 (1.8529) 10ª | 5.6733 (2.4057) 30 |
| Median (Min, Max) | 4.00 (2.00, 8.00) | 5.25 (2.50, 12.00) |
| No. of Fistula Openings: n/N (%)
Internal 1 opening: | 19/19 (100%) | 30/30 (100%) |
| Internal 2 openings: | -- | -- |
| External 1 opening: | 16/19 (84%) | 26/30 (87%) |
| External 2 openings: | 3/19 (16%) | 4/30 (13%) |
| Inner Fistula Diameter (cm):
Mean (SD) | Not Reported | 0.6017 (0.8391) |
| Median (Min, Max) | -- | 0.30 (0.05, 3.80) |
| Outer Fistula Diameter (cm):
Mean (SD) | Not Reported | 0.6137 (0.7834) |
| Median (Min, Max) | -- | 0.50 (0.01, 4.00) |
| Recurrent Fistula: n/N (%) | 12/19 (63%) | 20/30 (66.67%) |
| No. of Previous Fistula Treatments | 16 | 93 |
| Incontinence Score: Mean (Min, Max) | Not Performed | -- |
| Solid | -- | 0.23 (0, 4) |
| Liquid | -- | 0.67 (0, 4) |
| Gas | -- | 0.33 (0, 3) |
| Wears Pad | -- | 0.40 (0, 4) |
| Lifestyle Alteration | -- | 0.57 (0, 4) |
| Pain Scale:
Mean (Min, Max) | Not Performed | 3.83 (0, 8) |
Table 3: Comparison of Fistula Variables at Baseline
4Nine Historical Control subjects did not have fistula length recorded.
Incontinence Scale: 0=Never, 1=Rarely, 2=Sometimes, 3=Usually, 4=Always
Pain Scale: 0-10 (0=No pain, 5=Moderate pain, 10=Worst pain)
Table 4 provides the Month 6 fistula closure results for the control (GORE BIO-A Fistula Plug) and PICS-AF treatment groups.
Table 4: Fistula Closure Results at Month 6
| Treatment Group | Fistula Not Closed
n/N (%) | Fistula Closed
n/N (%) |
|-----------------|-------------------------------|---------------------------|
| PICS-AF | 16/30 (53.33%) | 14/30a (46.67%) |
| Control | 17/18b (94.44%) | 1/18 (5.56%) |
'Nine subjects were determined to have inclusion deviations that were detected by independent MRI readings. These subjects should not have been enrolled into this study. None of these nine subjects had healed fistulas at Month 6. The fistula closure success rate was 14/21 (66.67%) for subjects who met all specified enrollment criteria. bone Historical Control subject did not have an outcome recorded at six months.
11
Table 5 provides an analysis of the impact on fistula closure results based on the baseline characteristics for the combined treatment groups.
| Baseline Characteristic | Covariate P-value | P-value (Combined
Treatment Groups) |
|----------------------------|-------------------|----------------------------------------|
| Age | 0.6973 | 0.0179 |
| Weight | 0.3005 | 0.0244 |
| Gender | 0.0400 | 0.0174 |
| History of Diabetes | 0.7948 | 0.0176 |
| History of Cardiac Disease | 0.5648 | 0.0133 |
| History of Renal Disease | 0.9801 | 0.0115 |
| History of Smoking | 0.3127 | 0.0111 |
Table 5: Logistic Regression for Baseline Characteristic Impact on Fistula Closure
Table 6 provides a comparison of Month 6 outcomes for the control (GORE BIO-A Fistula Plug) and PICS-AF treatment groups.
| Category | Control
N=19 | PICS-AF
N=30 |
|-------------------------------------|-----------------|-----------------|
| Fistula Healed: n/N (%) | 1/18ª (5.56%) | 14/30 (46.67%) |
| Incontinence Score: Mean (Min, Max) | Not Performed | |
| Solid | -- | 0.27 (0, 3) |
| Liquid | -- | 0.97 (0, 4) |
| Gas | -- | 1.03 (0, 4) |
| Wears Pad | -- | 1.30 (0, 4) |
| Lifestyle Alteration | -- | 1.00 (0, 4) |
| Pain Scale: | Not Performed | |
| Mean (Min, Max) | -- | 2.37 (0, 10) |
4One Historical Control subject did not have an outcome recorded at six months. Incontinence Scale: 0=Never, 1=Rarely, 2=Sometimes, 3=Usually, 4=Always
Pain Scale: 0-10 (0=No pain, 5=Moderate pain, 10=Worst pain)
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Table 7 provides a summary of the adverse events (including serious adverse events) for the control (GORE BIO-A Fistula Plug) and PICS-AF treatment groups.
| Table 7: Adverse Events | |
|---|---|
| ------------------------- | -- |
| Control | PICS-AF | |||
|---|---|---|---|---|
| Adverse Event | Number of | |||
| Patients n/N | ||||
| (%) | Number | |||
| of | ||||
| Events | Number of | |||
| Patients n/N | ||||
| (%) | Number | |||
| of | ||||
| Events | ||||
| Primary Safety Endpointa | 0/19 (0%) | 0 | 3/30 (10.00%) | 3 |
| Any Adverse Event | 7/19 (36.84%) | 7 | 15/30 (50.00%) | 17d |
| Hypertension | 0/19 (0%) | 0 | 1/30 (3.33%) | 1 |
| Fistula-related Infection | 0/19 (0%) | 0 | 2/30 (6.67%) | 2 |
| Skin Irritation | 0/19 (0%) | 0 | 1/30 (3.33%) | 1 |
| Pain and Discomfort | 0/19 (0%) | 0 | 4/30 (13.33%) | 4 |
| Other Fistula-related | ||||
| Complicationb | 0/19 (0%) | 0 | 2/30 (6.67%) | 2 |
| Premature Pullout of the | ||||
| Anchor Suture and Partial | ||||
| Migration | 1/19 (5.26%) | 1 | 0/30 (0%) | 0 |
| Fistula Abscessc | 2/19 (10.53%) | 2 | 1/30 (3.33%) | 1 |
| New Fistula | 2/19 (10.53%) | 2 | 0/30 (0%) | 0 |
| Recurrence of Treated Fistula | ||||
| Tract | 1/19 (5.26%) | 1 | 0/30 (0%) | 0 |
| Fistula Tract Bleeding | 1/19 (5.26%) | 1 | 0/30 (0%) | 0 |
| Infection – Fistula Tract | 0/19 (0%) | 0 | 1/30 (3.33%) | 1 |
| Other | 0/19 (0%) | 0 | 2/30 (6.67%) | 2 |
4Fistula abscess requiring IV antibiotics and extended hospitalization (SAE).
°One mild external orifice and one anal canal ulcer.
6Excludes the two fistula abscesses that were primary safety endpoint events.
dTwo subjects had two Events each.
Table 8 summarizes the PICS-AF fistula healing outcomes based upon: subjects with adverse events and not healed fistulas; subjects with adverse events and healed fistulas; and subjects with no adverse events and not healed fistulas.
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| PICS-AF Subjects with Adverse Events and Not Healed Fistulas (n=11) | |||||
|---|---|---|---|---|---|
| No. Subjects | No. Adverse Events | No. Serious Adverse Events | Type of Intervention n/N (%) | Solid Incontinence n/N (%) | Pain Scale Score Mean (Min, Max) |
| 11 | 11 | 2 | Sealing Disk removed = 3/11 (27%) | ||
| Setons placed = 1/11 (9%) | |||||
| Drainage performed = 2/11 (18%) | |||||
| Medications prescribed = 3/11 (27%) | 0=Never: 8/11 (73%) | ||||
| 1=Rarely: 2/11 (18%) | |||||
| 2=Sometimes: 0/11 (0%) | |||||
| 3=Usually: 1/11 (9%) | |||||
| 4=Always: 0/11 (0%) | 3.27 (0, 8) | ||||
| PICS-AF Subjects with Adverse Events and Healed Fistulas (n=4) | |||||
| No. Subjects | No. Adverse Events | No. Serious Adverse Events | Type of Intervention n/N (%) | Solid Incontinence n/N (%) | Pain Scale Score Mean (Min, Max) |
| 4 | 3 | 1 | Sealing Disk removed = 1/4 (25%) | ||
| Setons placed = 0/4 (0%) | |||||
| Drainage performed = 2/4 (50%) | |||||
| Medications prescribed = 3/4 (75%) | 0=Never: 4/4 (100%) | ||||
| 1=Rarely: 0/4 (0%) | |||||
| 2=Sometimes: 0/4 (0%) | |||||
| 3=Usually: 0/4 (0%) | |||||
| 4=Always: 0/4 (0%) | 3.0 (0, 10) | ||||
| PICS-AF Subjects with No Adverse Events and Not Healed Fistulas (n=5) | |||||
| No. Subjects | No. Adverse Events | No. Serious Adverse Events | Type of Intervention n/N (%) | Solid Incontinence n/N (%) | Pain Scale Score Mean (Min, Max) |
| 5 | 0 | 0 | Sealing Disk removed = 0/5 (0%) | ||
| Setons placed = 0/5 (0%) | |||||
| Drainage performed = 0/5 (0%) | |||||
| Medications prescribed = 0/5 (0%) | 0=Never: 5/5 (100%) | ||||
| 1=Rarely: 0/5 (0%) | |||||
| 2=Sometimes: 0/5 (0%) | |||||
| 3=Usually: 0/5 (0%) | |||||
| 4=Always: 0/5 (0%) | 1.6 (0, 5) |
| Table 8: Summary of PICS-AF Fistula Healing Outcomes at Month 6 | |||
|---|---|---|---|
In conclusion, the collective data from the PICS-AF Clinical Study support the overall safety and effectiveness of the PICS-AF Closure System for the repair of anorectal fistulas. The PICS-AF Closure System has been demonstrated to have favorable effectiveness results for fistula closure and to have an acceptable safety profile.
CONCLUSIONS [807.92(b)(3)]
Extensive bench and clinical testing have been performed on the CuraSeal PICS-AF Closure System to evaluate the overall performance of the device. The collective results confirm that the CuraSeal PICS-AF Closure System is safe and effective, functions according to its specifications, is biocompatible and exhibits the appropriate mechanical and functional characteristics for an anorectal fistula repair device.
SUMMARY
The CuraSeal PICS-AF Closure System is considered to be substantially equivalent to the predicate devices.