(118 days)
Not Found
No
The 510(k) summary describes a surgical suture and its performance testing, with no mention of AI or ML technology.
No
The device is a surgical suture used for approximation and/or ligation of soft tissue, which is a structural or supportive function rather than a therapeutic one.
No
The device description clearly states it is a surgical suture used for approximation and/or ligation of soft tissues, which are therapeutic actions, not diagnostic.
No
The device is a physical surgical suture made of PTFE, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in all types of soft tissue approximation and/or ligation, including dental and general surgeries." This describes a device used in vivo (within the body) for surgical procedures.
- Device Description: The description details a surgical suture, a physical material used to close wounds or tie off blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment. The performance studies focus on the physical properties of the suture and its biocompatibility for implantation.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is a surgical tool used directly on the patient's tissues.
N/A
Intended Use / Indications for Use
PTFE (polytetrafluoroethylene) suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries
Product codes (comma separated list FDA assigned to the subject device)
NBY
Device Description
The LOOK™ PTFE Suture is a monofilament, synthetic, non-absorbable, sterile surgical suture composed of high-density polytetraflouroethylene (PTFE). PTFE Suture is provided undyed (White).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical laboratory performance testing was conducted to confirm that the LOOKTM PTFE Suture conforms to the USP monograph for nonabsorbable sutures for tensile strength and needle attachment. This testing was also conducted to show that the candidate device is substantially equivalent to the predicate devices. This testing was performed in accordance with FDA's Class II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.
Testing was conducted on the LOOKTM PTFE Suture to establish the device expiration date of five years. This testing was performed on both accelerated and real-time aged products. Accelerated aging was performed in accordance with ASTM F1980. The testing of the candidate device was conducted to confirm that the LOOKTM PTFE Suture conforms to the USP monograph for nonabsorbable sutures for tensile strength and needle attachment for the entire shelf life of the product.
Testing performed on the LOOKTM PTFE Suture included the following:
• Diameter per USP ;
• Needle Attachment per USP ;
• Tensile Strength per USP ;
All of the acceptance criteria were met at all testing intervals.
Biocompatibility testing for the LOOKTM PTFE Suture was conducted in accordance with the International Standard ISO 10993-1:2009 "Biological Evaluation of Medical devices- Part 1: Evaluation and testing within a risk management process". A Biological Risk Assessment was conducted for the testing recommended per ISO 10993-1:2009. As a function of the risk assessment, a subset of biocompatibility testing was performed to ensure compliance of the candidate device.
Per ISO 10993-1:2009, the LOOKTM PTFE Suture is classified as an implant, permanent contact (>30 days) with tissue/bone.
Assessments of the candidate device included the following:
• Biological Risk Assessment
• Cytotoxicity Study Using the ISO Elution Method
• ISO Intracutaneous Study in Rabbits
• ISO Guinea Pig Maximization Sensitization Test
• Endotoxin Test
• Material-mediated Rabbit Pyrogen Test
All of the acceptance criteria were met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.
(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
Surgical Specialties Corporation Ms. Karen Sanchez Regulatory Affairs Specialist Corredor Tijuana-Rosarito 2000, #24702-B Ejido Francisco Villa Tijuana, B.C., C.P. 22235 Mexico
Re: K160744
Trade/Device Name: LOOKTM PTFE Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: June 22, 2016 Received: June 24, 2016
Dear Ms. Sanchez:
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 yours,
David Krause -S
for 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
Indications for Use
510(k) Number (if known)
Device Name LOOK™ PTFE Suture
Indications for Use (Describe)
PTFE (polytetrafluoroethylene) suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries
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
Section 5 - 510(k) Summary
| Date Prepared: | June 30, 2016 | ||
|---|---|---|---|
| Company: | Surgical Specialties Corporation | ||
| Corredor Tijuana-Rosarito 2000 | |||
| #24702-B, Ejido Francisco Villa | |||
| Tijuana, B.C., C.P. 22235, Mexico | |||
| Contact: | Karen Sanchez | ||
| Regulatory Affairs Specialist | |||
| Phone: 484-557-4996 | |||
| Fax: 610-404-3905 | |||
| Email: ksanchez@surgicalspecialties.com | |||
| Device trade name: | LOOK™ PTFE Suture | ||
| Device Common Name: | PTFE Nonabsorbable Surgical Sutures | ||
| Device classification: | Non-absorbable expanded polytetrafluoroethylene surgical suture | ||
| Product Code, NBY | |||
| 21 CFR 878.5035 | |||
| Class II | |||
| Legally marketed devices to which the device is substantially equivalent: | K072076 | Cytoplast PTFE Suture | |
| K140415 | MonoTex PTFE Suture | ||
| Description of the device: | The LOOK™ PTFE Suture is a monofilament, synthetic, non-absorbable, sterile surgical suture composed of high-density polytetraflouroethylene (PTFE). PTFE Suture is provided undyed (White). | ||
| Indications for Use: | The LOOK™ PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. |
4
Substantial Equivalence:
The LOOK™ PTFE Suture is substantially equivalent to the predicates Cytoplast PTFE suture and MonoTex PTFE Suture in which the basic features and intended uses are the same. Any differences between the LOOK™ PTFE Suture and the predicates are considered minor and do not raise questions concerning safety and effectiveness.
| | LOOKTM PTFE
Braided Suture | Cytoplast PTFE
Suture
(K072076) | MonoTex PTFE
Suture
(K140415) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|----------------------------------------|
| Product Code | NBY | Identical | Identical |
| Suture
Characteristic | Non-absorbable
expanded
polytetrafluoroethylene
surgical suture | Identical | Identical |
| Intended Use | Approximation or
ligation of soft tissues | Identical | Identical |
| Technological
Characteristic | Monofilament, uncoated,
synthetic nonabsorbable
surgical sutures | Identical | Identical |
| Material | High-density
polytetrafluoroethylene
(PTFE) | Identical | Identical |
| Sizes | 2-0, 3-0, 4-0, 5-0, 6-0 in
18" lengths | 2-0, 3-0, 4-0 in 18"
lengths | Identical to proposed
device |
| Sterilization | EO | Identical | Identical |
| Packaging | Device wound onto inner
support card, within a
Tyvek/Poly Primary
Pouch; inside a Tyvek /
Poly secondary pouch | Device wound onto
inner support card,
within a Tyvek /
Poly pouch | Device packaged in
racetrack design |
5
| Performance tests: | Non-clinical laboratory performance testing was conducted to confirm that the
LOOKTM PTFE Suture conforms to the USP monograph for nonabsorbable
sutures for tensile strength and needle attachment. This testing was also
conducted to show that the candidate device is substantially equivalent to the
predicate devices. This testing was performed in accordance with FDA's Class
II Special Controls Guidance Document: Surgical Sutures, Issued June 3, 2003.
Testing was conducted on the LOOKTM PTFE Suture to establish the device
expiration date of five years. This testing was performed on both accelerated
and real-time aged products. Accelerated aging was performed in accordance
with ASTM F1980. The testing of the candidate device was conducted to
confirm that the LOOKTM PTFE Suture conforms to the USP monograph for
nonabsorbable sutures for tensile strength and needle attachment for the entire
shelf life of the product.
Testing performed on the LOOKTM PTFE Suture included the following:
• Diameter per USP
• Needle Attachment per USP ;
• Tensile Strength per USP ;
All of the acceptance criteria were met at all testing intervals. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility
Testing | Biocompatibility testing for the LOOKTM PTFE Suture was conducted in
accordance with the International Standard ISO 10993-1:2009 "Biological
Evaluation of Medical devices- Part 1: Evaluation and testing within a risk
management process". A Biological Risk Assessment was conducted for the
testing recommended per ISO 10993-1:2009. As a function of the risk
assessment, a subset of biocompatibility testing was performed to ensure
compliance of the candidate device.
Per ISO 10993-1:2009, the LOOKTM PTFE Suture is classified as an implant,
permanent contact (>30 days) with tissue/bone.
Assessments of the candidate device included the following:
• Biological Risk Assessment
• Cytotoxicity Study Using the ISO Elution Method
• ISO Intracutaneous Study in Rabbits
• ISO Guinea Pig Maximization Sensitization Test
• Endotoxin Test
• Material-mediated Rabbit Pyrogen Test
All of the acceptance criteria were met. |
| Summary | The results of the testing demonstrate that the LOOKTM PTFE Suture is
substantially equivalent in safety and performance to the predicate devices. |