(83 days)
Not Found
No
The device description and performance studies focus on mechanical function and material properties, with no mention of AI, ML, or data processing for decision-making or analysis.
No.
The device is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures, serving as a surgical tool rather than a device for treating a disease or condition.
No.
The device is intended for manipulation and fluid injection during surgical and diagnostic laparoscopic procedures, not for identifying the presence, nature, or extent of a disease or condition. While it can be used during "diagnostic laparoscopy," its role is procedural (manipulation, fluid injection, maintaining pneumoperitoneum), not diagnostic in itself.
No
The device description clearly outlines physical components such as a cannula, sliding tube, handle, luer port, collars, and a stabilizer, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for the manipulation of the uterus and injection of fluids during laparoscopic procedures. This is a surgical/procedural use, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a physical device designed for insertion into the body to manipulate organs and inject fluids. It does not describe a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
The device is a surgical instrument used during a procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Unicare System is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum during a colpotomy.
The Unicare Manipulator is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures, such as minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy.
Product codes
LKF
Device Description
The new Unicare System™ is a sterile, disposable, single-use device for manipulation of the uterus and cervix during surgical and diagnostic procedures. The Unicare System™ consists of the Unicare Manipulator™, a rear Stabilizer™, and a set of interchangeable, forward Collars™
The Unicare Manipulator™ is a rigid, anatomically curved cannula having at its proximal end a tip for insertion into the uterus to manipulate and maintain the proper attitude of the uterus. The Unicare Manipulator incorporates a sliding tube component with a proximal ball that provides a positive stop from over-penetration of the uterine cavity and counter traction with the tip for manipulation. At the distal end of the device is a handle which allows the surgeon to manipulate the uterus to the position most desirable for the procedure being performed. At the extreme distal end of the device is a standard luer port suitable for attachment of a standard syringe for injection of fluids or gases into the uterus through the cannula.
The Unicare System also incorporates a set of interchangeable, forward Collars™ and a rear Stabilizer™. The appropriately sized Collar surrounds the cervix, delineates the fornix, and supports and defines the vaginal wall. The rear Stabilizer and a sliding tube are slid along the cannula to adjust the depth of tip insertion and seal the vaginal cavity from within to maintain pneumoperitoneum and prevent abdominal deflation once the vagina is entered during laparoscopic procedures such as during a colpotomy. The rear Stabilizer and sliding tube components are secured at their proper depth with a locking mechanism situated distal to the sliding tube and external to the patient.
The Unicare Manipulator™ will be offered and sold separately from the Unicare System™. The Unicare Manipulator"™ does not include a rear Stabilizer" or a set of interchangeable, forward Collars", and is therefore indicated only for a subset of procedures of the Unicare System™
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
uterus and cervix
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical Professionals / Clinical Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
type: Biocompatibility
description: Biocompatibility of the subject devices was tested per ISO 10993-1 (2009/(R)2013) Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process.
key results: The Unicare System™ and Unicare Manipulator™ were found to be noncytotoxic, non-irritating, non-sensitizing, and not acutely toxic.
type: Non-Clinical Performance Testing
description: Non-clinical product testing of the new Unicare System™ and Unicare Manipulator "" was completed and met all of the acceptance criteria. Testing included Mechanical, Packaging, Sterility, and Accelerated aging.
key results: The acceptance criteria were met for all non-clinical performance testing of the new Unicare System™ and Unicare Manipulator™. The results demonstrate the subject devices are as safe and effective as the predicate.
type: Clinical Performance Testing
description: No clinical testing has been performed in support of this Unicare System™ and Unicare Manipulator™ 510(k) submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
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 stylized caduceus symbol, which features a staff with a snake entwined around it, overlaid on three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2017
ClearPath Surgical, Inc. Puja Ohlhaver CEO 1052 High Street Palo Alto, CA 94301
Re: K163214
Trade/Device Name: Unicare System & Unicare Manipulator Regulation Number: None Regulation Name: None Regulatory Class: Unclassified Product Code: LKF Dated: November 14, 2016 Received: November 16, 2016
Dear Puja Ohlhaver:
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.
1
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Joyce M. Whang -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Unicare System & Unicare Manipulator
Indications for Use (Describe)
The Unicare System is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum during a colpotomy.
The Unicare Manipulator is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures, such as minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy.
| 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) |
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3
510(k) SUMMARY
| Date Prepared: | January 30, 2017 |
|---|---|
| Submitter: | ClearPath Surgical, Inc. |
| 1052 High St. | |
| Palo Alto, CA 94301 | |
| Telephone: 1 (888) 979-7467 ext. 700 | |
| Fax: 1 (888) 979-6685 | |
| Contact: | Puja Ohlhaver |
| CEO | |
| puja@clearpathsurgical.com | |
| Telephone: 1 (888) 979-7467 ext. 700 | |
| Fax: 1 (888) 979-6685 | |
| Classification: | Unclassified |
| Product Code: | LKF |
| Product Code Name: | Cannula, Manipulator/Injector, Uterine |
| Trade/Proprietary | |
| Name of Device: | Unicare System™ and Unicare Manipulator™ |
| Common Name: | Uterine Manipulator |
| Legally Marketed | |
| Predicate Device: | VCARE manufactured by Conmed Corporation, |
| K071907 (Oct. 5, 2007), Product code LKF | |
| Predicate Device | |
| Design-related Recalls: | There are no design related recalls associated with |
| the predicate device. |
Description of the new Unicare System™ and Unicare Manipulator™:
The new Unicare System™ is a sterile, disposable, single-use device for manipulation of the uterus and cervix during surgical and diagnostic procedures. The Unicare System™ consists of the Unicare Manipulator™, a rear Stabilizer™, and a set of interchangeable, forward Collars™
The Unicare Manipulator™ is a rigid, anatomically curved cannula having at its proximal end a tip for insertion into the uterus to manipulate and maintain the proper attitude of the uterus. The Unicare Manipulator incorporates a sliding tube component with a proximal ball that provides a positive stop from
4
over-penetration of the uterine cavity and counter traction with the tip for manipulation. At the distal end of the device is a handle which allows the surgeon to manipulate the uterus to the position most desirable for the procedure being performed. At the extreme distal end of the device is a standard luer port suitable for attachment of a standard syringe for injection of fluids or gases into the uterus through the cannula.
The Unicare System also incorporates a set of interchangeable, forward Collars™ and a rear Stabilizer™. The appropriately sized Collar surrounds the cervix, delineates the fornix, and supports and defines the vaginal wall. The rear Stabilizer and a sliding tube are slid along the cannula to adjust the depth of tip insertion and seal the vaginal cavity from within to maintain pneumoperitoneum and prevent abdominal deflation once the vagina is entered during laparoscopic procedures such as during a colpotomy. The rear Stabilizer and sliding tube components are secured at their proper depth with a locking mechanism situated distal to the sliding tube and external to the patient.
The Unicare Manipulator™ will be offered and sold separately from the Unicare System™. The Unicare Manipulator"™ does not include a rear Stabilizer" or a set of interchangeable, forward Collars", and is therefore indicated only for a subset of procedures of the Unicare System™
Table 1.1 lists the key components and their respective materials. The new Unicare System™ and Unicare Manipulator™ have limited surface contact of less than or equal to 24 hours as categorized per ISO 10993-1:2009.
5
| UNICARE SYSTEM &
UNICARE
MANIPULATOR | Materials | Direct Patient
Contact |
|-------------------------------------------------|-----------|---------------------------|
| Cannula | Steel | Yes |
| Tip | Polymer | Yes |
| Cannula Insulation (i.e.
Heat Shrink Tubing) | Polymer | Yes |
| Handle | Polymer | No |
| Lock Body | Polymer | Yes |
| Thumbscrew | Polymer | Yes |
| Cap | Polymer | No |
| Sliding Tube | Polymer | Yes |
| Luer Port | Polymer | No |
| String* | Suture | Yes |
| Collars* | Polymer | Yes |
| Stabilizer * | Polymer | Yes |
| Retrieval Ring* | Polymer | Yes |
Table 1.1 - List of Materials
(* indicates components of Unicare System only)
Indications for Use:
The Unicare System™ is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures such as Laparoscopic Assisted Vaginal Hysterectomy (LAVH), Total Laparoscopic Hysterectomy (TLH), minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy and also maintains pneumoperitoneum during a colpotomy.
The Unicare Manipulator™ is indicated for manipulation of the uterus and injection of fluids during laparoscopic procedures, such as minilap, laparoscopic tubal occlusion, or diagnostic laparoscopy.
6
Comparison of the Technological Features to the Predicate Device:
The new Unicare System™ and Unicare Manipulator™ are substantially equivalent to the predicate ConMed VCARE Retractor/Elevator (K071907). The new and predicate devices are very similar in overall design and technology, principles of operation, and intended use.
The main differences between the new Unicare System™ and Unicare Manipulator "10 and the predicate VCARE Retractor/Elevator (K071907) device are the following:
-
- The new Unicare System™ and Unicare Manipulator™ utilize a bulbousshaped tip instead of the predicate device's inflatable balloon tip.
-
- The new Unicare System™ includes a rear Stabilizer and a set of forward interchangeable Collars, whereas the predicate VCARE includes a rear cup and a fixed forward cup.
-
- The new Unicare System™ includes a Retrieval Ring and String attached to the forward Collar to facilitate retrieval of the Collar, whereas the predicate device's forward cup lacks a Retrieval Ring and String.
-
- The new Unicare System™ secures the cervix with a suture applied on the rear Stabilizer, whereas the predicate device secures the cervix with a suture applied on the forward cup.
The differences between the new Unicare System™ and Unicare Manipulator™ and the predicate ConMed VCARE (K071907) device do not raise different questions of safety of effectiveness.
Table 1.2 below shows selected properties and characteristics of the new Unicare System™ and Unicare Manipulator™ and the predicate ConMed VCARE (K071907) device.
7
Device Comparison Table 1.2
| Descriptive
Information | Results: NEW UNICARE SYSTEM
& UNICARE MANIPULATOR | Results: PREDICATE DEVICE:
ConMed VCARE (K071907) | Substantial Equivalence |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The UNICARE SYSTEM is
indicated for manipulation of the
uterus and injection of fluids during
laparoscopic procedures such as
Laparoscopic Assisted Vaginal
Hysterectomy (LAVH), Total
Laparoscopic Hysterectomy (TLH),
minilap, laparoscopic tubal
occlusion, or diagnostic laparoscopy
and also maintains
pneumoperitoneum during a
colpotomy.
The UNICARE MANIPULATOR is
indicated for manipulation of the
uterus and injection of fluids during
laparoscopic procedures, such as
minilap, laparoscopic tubal
occlusion, or diagnostic
laparoscopy. | The VCARE Retractor/Elevator is
indicated for manipulation of the
uterus and injection of fluids or
gases during laparoscopic
procedures such as Laparoscopic
Assisted Vaginal Hysterectomy
(LAVH), Total Laparoscopic
Hysterectomy (TLH), minilap,
laparoscopic tubal occlusion, or
diagnostic laparoscopy and also
maintains pneumoperitoneum by
sealing the vagina once a colpotomy
is performed. | Similar. The Unicare
System's indications are
nearly identical to
VCARE's indications. The
Unicare System is
indicated for "injection of
fluids" whereas VCARE is
indicated for "injection of
fluids or gases.” Unicare
"maintains
pneumoperitoneum during
a colpotomy," whereas
VCARE "maintains
pneumoperitoneum by
sealing the vagina once a
colpotomy is performed."
These differences do not
change the Unicare
System's intended use.
Similar, the Unicare
Manipulator's indications
are a subset of the Unicare
System's indications and
are therefore included
within the predicate
VCARE's indications |
8
| Product
| Code | LKF | LKF | Same |
|---|---|---|---|
| Intended | |||
| Users | Medical Professionals | Medical Professionals | Same |
| Environment | |||
| of Use | Clinical Setting | Clinical Setting | Same |
| Single-Use | Yes | Yes | Same |
| Sterile | Yes (Ethylene Oxide) | Yes (Radiation) | Similar - both products are |
| sterile | |||
| Materials | Materials for NEW UNICARE | ||
| SYSTEM & UNICARE | |||
| MANIPULATOR | Materials for PREDICATE DEVICE: | ||
| ConMed VCARE (K071907) | Substantial Equivalence | ||
| Cannula | stainless steel | stainless steel | Same |
| Tip | hard thermoplastic | synthetic plastic polymer | Similar - both products are |
| made of polymers. | |||
| Collars | hard thermoplastic | hard thermoplastic | Similar - both products are |
| made of polymers. | |||
| Stabilizer | hard thermoplastic | flexible thermoplastic | Similar - both products are |
| made of polymers. | |||
| Retrieval | |||
| Ring | hard thermoplastic | N/A | No new question of safety |
| and effectiveness | |||
| Cannula | |||
| Insulation | |||
| (i.e. Heat | |||
| Shrink | |||
| Tubing) | polymer | polymer | Similar - both products are |
| made of polymers. | |||
| Handle | hard thermoplastic | hard thermoplastic | Similar - both products are |
| made of polymers. | |||
| Lock Body | hard thermoplastic | hard thermoplastic | Similar - both products are |
| made of polymers. | |||
| Thumbscrew | hard thermoplastic | hard thermoplastic | Similar - both products are |
| made of polymers. | |||
| Cap | hard thermoplastic | hard thermoplastic | Similar - both products are |
| made of polymers. | |||
| String | suture | N/A | No new question of safety |
| and effectiveness | |||
| Sliding Tube | flexible thermoplastic | flexible thermoplastic | Similar - both products are |
| made of polymers. | |||
| Luer Port | hard thermoplastic | hard thermoplastic | Similar - both products are |
| made of polymers. | |||
| Luer Fitting | hard thermoplastic | hard thermoplastic | Similar - both products are |
| made of polymers. | |||
| Ink | ink | ink | Similar - both are inks. |
| Features | NEW UNICARE SYSTEM & | ||
| UNICARE MANIPULATOR | PREDICATE DEVICE: ConMed | ||
| VCARE (K071907) | Substantial Equivalence | ||
| Electrically | |||
| insulated | |||
| Cannula | yes | yes | Same |
| Hollow | |||
| Cannula | yes | yes | Same |
| Distal | |||
| Cannula | |||
| Curvature | yes | yes | Same |
| Graduation | |||
| marks | |||
| measuring | |||
| distance | |||
| from most | |||
| proximal | |||
| point on tip | yes | yes | Same |
| Bulbous tip | yes (Rigid) | yes (Inflatable) | Similar – No different questions of safety and effectiveness |
| Tip enables | |||
| direct | |||
| introduction | |||
| of | |||
| dye/contrast | |||
| media via the | |||
| Luer Port | yes | yes | Same |
| Standard | |||
| Luer Port | |||
| suitable for | |||
| attachment | |||
| of a | |||
| standard | |||
| syringe | yes | yes | Same |
| Continuous | |||
| flow | |||
| between | |||
| Luer Port | |||
| and Tip | yes | yes | Same |
| Cap to seal | |||
| Luer Port | yes | yes | Same |
| Sliding Tube | |||
| that slides | |||
| along the | |||
| Cannula | yes | yes | Same |
| Lock Body | yes | yes | Same |
| Thumbscrew | yes | yes | Same |
| Rear | |||
| Stabilizer | yes (System only) | yes, rear cup | Similar - No different |
| questions of safety and | |||
| effectiveness | |||
| Forward | |||
| Collar | yes (System only) | yes, forward cup | Similar - No different |
| questions of safety and | |||
| effectiveness | |||
| Double rim | |||
| on forward | |||
| Collar | yes (System only) | yes, on forward cup | Same |
| Multiple size | |||
| forward | |||
| Collars | yes, interchangeable Collars on | ||
| single device (System only) | yes, multiple devices | Similar - No different | |
| questions of safety and | |||
| effectiveness | |||
| Holes to | |||
| allow | |||
| securing the | |||
| cervix with a | |||
| suture | yes, the rear Stabilizer includes | ||
| suture holes (System only) | yes, the forward cup includes suture | ||
| holes | Similar - No different | ||
| questions of safety and | |||
| effectiveness | |||
| Collars to | |||
| support the | |||
| cervix | yes, interchangeable forward Collars | ||
| (System only) | yes, fixed forward cup | Similar - No different | |
| questions of safety and | |||
| effectiveness |
9
10
11
In conclusion, the differences in technological characteristics identified in the table above do not raise different questions of safety and effectiveness.
12
Testing:
Differences in technological characteristics were evaluated through performance testing.
Biocompatibility:
Biocompatibility of the subject devices was tested per ISO 10993-1 (2009/(R)2013) Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, and they included:
- Cytotoxicity: ISO 10993-5 (2009/(R)2014) Biological evaluation of . medical devices -- Part 5: Tests for in vitro cytotoxicity
- Sensitivity: ISO 10993-10 (2010/(R)2014) Biological evaluation of ● medical devices -- Part 10: Tests for irritation and skin sensitization
- Irritability: ISO 10993-10 (2010/(R)2014) Biological evaluation of ● medical devices -- Part 10: Tests for irritation and skin sensitization
- . Systemic Toxicity: ISO 10993-11 (2006) Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
The Unicare System™ and Unicare Manipulator™ were found to be noncytotoxic, non-irritating, non-sensitizing, and not acutely toxic.
Non-Clinical Performance Testing:
Non-clinical product testing of the new Unicare System™ and Unicare Manipulator "" was completed and met all of the acceptance criteria. Testing included the following:
- Mechanical: the device was evaluated for mechanical performance ● including flow rates, strength and applied clinical forces.
- . Packaging: the device packaging was evaluated for structural integrity and maintenance of the sterile barrier after transit per ASTM F1886/F1886M-09:2013 (Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection), ASTM F2096-11:2011 (Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization), and ASTM F88/F88M-15:2015 (Seal Strength).
- . Sterility: the device was evaluated for sterility per ISO 11137-1:2013 (Sterilization of health care products - Radiation - Part 1: Requirements for Development Validation and routine control of a sterilization process
13
for medical devices) and ISO 11137-2:2013 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose) .
- Accelerated aging: the device was evaluated for non-clinical performance ● after aging. ASTM F1980-07:2011 (Guide for Accelerated Aging of Sterile. Medical Device Packages).
The acceptance criteria were met for all non-clinical performance testing of the new Unicare System™ and Unicare Manipulator™. The results demonstrate the subject devices are as safe and effective as the predicate.
Clinical Performance Testing:
No clinical testing has been performed in support of this Unicare System™ and Unicare Manipulator™ 510(k) submission.
Conclusion of Substantial Equivalence:
The indications for use and basic technological characteristics of the Unicare System™ and Unicare Manipulator™ are similar to those of the predicate. Minor differences in the indications for use of the Unicare System™ and Unicare Manipulator™ do not alter the intended use from that of the predicate. Differences in technological characteristics between the subject devices and the predicate do not raise different questions of safety and effectiveness. The performance testing provided support that the subject devices are as safe and effective as the predicate. Therefore, the Unicare System "" and Unicare Manipulator™ are substantially equivalent to the predicate.