CARESORB® - Polyglactin 910 Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures; but not for use in cardiovascular or neurological tissues.

CARESORB® RAPID - Polyglactin 910 (fast absorbing) Surgical Sutures are indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

Device Description

The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are multifilament, braided, sterile synthetic absorbable surgical sutures composed of a copolymer of 90% glycolide and 10% L-lactide. The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are coated with copolymer of Poly(glycolide-co-L-lactide) (30/70) and calcium stearate.

The CARESORB® - Polyglactin 910 suture is available dyed with FDA-approved color additive D&C Violet No. 2 - Cl 60725 or undyed in the natural beige color.

The CARESORB® RAPID - Polyglactin 910 suture is available undyed in the natural beige color only.

The CARESORB® sutures are available in USP sizes 6-0 through 1 and CARESORB® RAPID sutures in USP sizes 4-0 through 2-0, in different lengths, with or without a standard needle attached.

The CARESORB® and CARESORB® RAPID sutures meet USP Monograph for Synthetic Absorbable Sutures, except for diameter.

AI/ML Overview

The document describes the non-clinical testing performed to demonstrate the substantial equivalence of CARESORB® and CARESORB® RAPID surgical sutures to predicate devices (Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide). The study is not an AI/ML study, but rather a set of laboratory and in-vivo tests for medical device acceptance.

Here is an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Study Type and Purpose:
This is a non-clinical comparative study designed to establish substantial equivalence of new surgical sutures (CARESORB® and CARESORB® RAPID) to existing legally marketed predicate devices (Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide). The goal is to demonstrate that the new devices are as safe and effective as the predicates.

Acceptance Criteria and Reported Device Performance:

The acceptance criteria are generally implied by "compliance with" various USP monographs and ISO standards, and "similarity"/ "comparability" to the predicate devices. The reported device performance is presented as the test outcomes indicating this compliance or similarity.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility
Compliance with ISO 10993-1, -3, -5, -6, -7, -10, -11 requirements	- No evidence of cytotoxicity, irritation, delayed dermal sensitization, or acute systemic toxicity for CARESORB® Surgical Suture.- CARESORB® Surgical Suture considered non-irritant compared to predicate VICRYL™ in short-term, mid-term, and long-term Intramuscular Implantation Tests with Histopathology.- CARESORB® Rapid Surgical Suture considered non-irritant compared to predicate VICRYL™ Rapide in mid-term Intramuscular Implantation Test with Histopathology.- CARESORB® Suture found to be non-pyrogenic, non-mutagenic, and non-genotoxic.
Material & Physical Properties
Compliance with USP Monograph for Synthetic Absorbable Sutures	- CARESORB® and CARESORB® RAPID sutures meet USP Monograph for Synthetic Absorbable Sutures, except for diameter (stated to comply with USP <861> except for slight oversize).
Compliance with USP <861> Sutures Diameter	- Complies with USP <861> except for slight oversize in the suture diameter for both CARESORB® and CARESORB® RAPID.
Compliance with USP <871> Sutures Needle Attachment	- Complies with USP <871> for both CARESORB® and CARESORB® RAPID.
Compliance with USP <881> Tensile Strength	- Complies with USP <881> for both CARESORB® and CARESORB® RAPID.
Suture Length	- ≥ 95% of the claimed label length as required by USP for both CARESORB® and CARESORB® RAPID.
Absorption & Breaking Strength Retention Profile
Similar resorption profile to predicate device	- CARESORB® sutures have similar tensile strength retention profile in comparison to marketed predicate VICRYL™ sutures in an in-vivo implantation study.- In-vivo breaking strength retention profile of CARESORB® RAPID was determined to be similar to marketed predicate VICRYL™ Rapide (based on supplier data) and independently demonstrated similar resorption profiles in an in-vitro study compared to VICRYL™ Rapide and raw material sutures.- CARESORB® sutures and VICRYL™ sutures have very similar absorption in tissue in an in-vivo implantation study.- CARESORB® RAPID rate of absorption in tissue was determined to be similar to marketed predicate VICRYL™ Rapide (based on supplier data).
Sterility & Packaging
Validated sterile barrier packaging system	- Validated sterile barrier packaging system (Tested against ISO 11607-1, ASTM F88/F88M-15, ASTM F1140/F1140M-13, ASTM F2096-11).
Sterility (USP <71>)	- Sterility Testing (USP 39-NF34 <71>) performed as part of shelf-life study and overall compliance.
Minimal Ethylene Oxide Sterilization Residuals	- ISO 10993-7 Residuals testing performed. (Results not explicitly detailed, but implied compliance).
Absence of Bacterial Endotoxins	- USP 39-NF 34 <85> Bacterial Endotoxins Test performed. (Results not explicitly detailed, but implied compliance).
Shelf Life
Conformance for 5-year expiration date	- Conformance to specified acceptance criteria for diameter, needle attachment, tensile strength, in vitro BSR, visual inspection, moisture content, and sterility after real-time and accelerated aging studies. Supported a 5-year expiration date.

Detailed Information as requested:

Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test, but studies were conducted "in vivo" and "in vitro." Standard specifications like USP monographs and ISO standards imply a certain number of samples are required for testing. For instance, the discussion mentions "samples of final sterilized devices". In vivo studies likely involved animal models, but no numbers are provided.
- Data Provenance: The studies were conducted by CPT Sutures Co., Ltd. through various tests following international standards (ISO and USP). The in-vivo breaking strength retention and absorption rate for CARESORB® RAPID were based on "data provided by the suture material supplier from the in-vivo implantation study," suggesting external data provenance for part of the study for that specific product. The in vitro study for CARESORB® RAPID explicitly compared it to the predicate and "raw material supplier's sutures," indicating internally generated data. The document implies these are prospective tests conducted specifically for this submission. The country of origin for the submitting company is Vietnam.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is a medical device performance and equivalence study based on physical, chemical, and biological testing, not an AI/ML diagnostic study requiring expert human interpretation of medical images. The "ground truth" here is objective measurement against established standards (USP monographs, ISO standards) and comparison to the predicate device's known performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as this is not a study involving human readers/interpreters or subjective assessments requiring adjudication. The methods are standardized laboratory tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a MRMC study was not done. This is a study for validating medical device characteristics, not an AI/ML diagnostic performance study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is framed for AI/ML algorithms. For a medical device like a suture, the "standalone performance" refers to the intrinsic physical, chemical, and biological properties of the suture itself, which is precisely what the non-clinical tests (biocompatibility, tensile strength, absorption profile, etc.) evaluated. There is no algorithm involved.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this study is based on:
  - Industry Standards: Compliance with established physical and chemical properties defined by USP (United States Pharmacopeia) monographs and various ISO standards for biocompatibility (e.g., ISO 10993 series), sterility, and packaging.
  - Predicate Device Performance: Direct comparison of the new device's performance to the known and accepted performance characteristics of the legally marketed predicate devices (Ethicon's VICRYL™ and VICRYL™ Rapide) in terms of absorption profiles and other key parameters.
  - Laboratory Measurements: Objective measurements of tensile strength, diameter, needle attachment, absorption rates, and biological responses (e.g., cytotoxicity, irritation via histopathology).
The sample size for the training set:
- Not applicable. This is not an AI/ML study, so there is no "training set." The materials used for testing are representative samples of the manufactured surgical sutures.
How the ground truth for the training set was established:
- Not applicable. There is no AI/ML training set.

Summary

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Image /page/0/Picture/2 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" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they also resemble an abstract bird.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 29, 2017

CPT Sutures Co., Ltd. % Ms. Natalya Valerio Official Correspondent for CPT Sutures Co., Ltd. MDI Consultants. Inc. 55 Northern Blvd.. Suite 200 Great Neck, New York 11021

Re: K170166

Trade/Device Name: CARESORB® - Polyglactin 910 Surgical Suture, CARESORB RAPID® - Polyglactin 910 (fast Absorbing) Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: August 31, 2017 Received: September 1, 2017

Dear Ms. Valerio:

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

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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 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 (DICE) 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 (DICE) 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,

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

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Indications for Use

510(k) Number (if known) K170166

Device Name CARESORB® - Polyglactin 910 Surgical Suture

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Indications for Use

510(k) Number (if known) K170166

Device Name

CARESORB® RAPID - Polyglactin 910 (fast absorbing) Surgical Suture

Indications for Use (Describe)

CARESORB® RAPID Polyglactin 910 (fast absorbing) Surgical Sutures are indicated for use in superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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K170166 p. 1 of 7

510(k) SUMMARY

The assigned 510(k) number is: K170166

1. Submitter's Identification:

CPT Sutures Co., Ltd. 8 Dao Tri Street Phu Thuan Ward District 7, Ho Chi Minh, Vietnam

Date Summary Prepared: August 31, 2017

Mr. Khoa Do Contact: Vice Director CPT Sutures Co., Ltd. e-mail: khoa.do@cpt-medical.com phone: (+84) 28 38 222 228

2. Name of the Device:

Trade Name:	CARESORB® - Polyglactin 910 Surgical Suture andCARESORB® RAPID - Polyglactin 910 fast absorbingSurgical Suture
Common Name:	Suture, Absorbable, Synthetic, Polyglycolic Acid
Regulation Number:	21CFR 878.4493
Regulation Name:	Absorbable Poly(glycolide/L-lactide) Surgical Suture
Regulatory Class:	Class II
Product Code:	GAM

3. Information for the 510(k) Cleared Device (Predicate Device):

Ethicon's Coated VICRYL™ (Polyglactin 910) Synthetic Absorbable Suture, 510(k) # K022269

Ethicon's Coated VICRYL™ Rapide (Polyglactin 910) Synthetic Absorbable Suture, 510(k) # K033746

4. Device Description:

The CARESORB® - Polyglactin 910 suture is available dyed with FDA-approved color additive D&C Violet No. 2 - Cl 60725 or undyed in the natural beige color.

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The CARESORB® RAPID - Polyglactin 910 suture is available undyed in the natural beige color only.

The CARESORB® sutures are available in USP sizes 6-0 through 1 and CARESORB® RAPID sutures in USP sizes 4-0 through 2-0, in different lengths, with or without a standard needle attached.

The CARESORB® and CARESORB® RAPID sutures meet USP Monograph for Synthetic Absorbable Sutures, except for diameter.

5. Indications for Use:

6. Comparison to the 510(k) Cleared Devices (Predicate Devices):

ComparisonCriteria	New DeviceCARESORB® -Polyglactin 910Surgical Suture	New DeviceCARESORB® RAPID -Polyglactin 910Surgical Suture	PredicateDevice(s)
Predicate Device	Ethicon's CoatedVICRYL™ (Polyglactin910) SyntheticAbsorbable Suture,510(k) # K022269	Ethicon's CoatedVICRYL™ Rapide(Polyglactin 910)SyntheticAbsorbable Suture,510(k) # K033746	Image: checkerboard pattern
Classification	SyntheticAbsorbableSurgical Suture	SyntheticAbsorbableSurgical Suture	Same
Indicationsfor Use	General soft tissue approximation and / or ligation, including use in ophthalmic procedures, but not in cardiovascular or neurological tissues	Superficial soft tissue approximation of the skin and mucosa, where only short-term wound support (7-10 days) is required but not for use in ligation, ophthalmic, cardiovascular or neurological procedures	Same for eachrespectivepredicate
Suture Material	Copolymer of 90%glycolide and 10%L-lactide	Copolymer of 90%glycolide and 10%L-lactide	Same
MaterialPresentation	Multifilament, braided	Multifilament, braided	Same for eachrespectivepredicate
Coating	Coated with copolymerof Poly(glycolide-co-L-lactide) (30/70) andcalcium stearate	Coated with copolymerof Poly(glycolide-co-L-lactide) (30/70) andcalcium stearate	Same
Color Additive	Available dyed with FDA-approved color additiveD&C Violet No. 2 - Cl60725 as well as undyedin natural beige color	Available undyed only	Same for eachrespectivepredicate
Sterilization	Sterilized byEthylene Oxide	Sterilized byEthylene Oxide	VICRYL™ issterilized byEthylene OxideVICRYL™ Rapideis sterilized byGamma Irradiation
Single Use	Yes	Yes	Same
How Supplied	Sutures of variouslengths and gauge sizesof USP 6-0 to 1, with orwithout the standardstainless steel needle(series 302 with siliconcoating) attached.Available as one-dozenand three-dozen boxes.	Sutures of variouslengths and gauge sizesof USP 4-0 to 2-0, withor without the standardstainless steel needle(series 302 with siliconcoating) attached.Available as one-dozenand three-dozen boxes.	Sutures of variousgauge sizes andlengths, with orwithout standardstainless steelneedle attached.Available as one-dozen and three-dozen boxes.
AbsorptionProfile	Suture absorption beginsas a loss of tensilestrength followed byeventual absorption byhydrolysis. Completeabsorption occursbetween 56-70 days.	Suture absorption beginsas a loss of tensilestrength followed byeventual absorption byhydrolysis. Completeabsorption occurs in 42days.	Same for eachrespectivepredicate
BreakingStrengthRetention Profile	Percent BreakingStrength Retention (%BSR): > 65% at 14 days;> 40% at 21 days.	Percent BreakingStrength Retention (%BSR): 50% at 5 days;0% at 14 days.	Same for eachrespectivepredicate
Suture Diameter	Complies withUSP <861> except forslight oversize in thesuture diameter	Complies withUSP <861> except forslight oversize in thesuture diameter	Same
Suture Length	≥ 95% of the claimedlabel length as requiredby USP	≥ 95% of the claimedlabel length as requiredby USP	Same
NeedleAttachment	Complies withUSP <871>	Complies withUSP <871>	Same
Tensile Strength	Complies withUSP <881>	Complies withUSP <881>	Same
Biocompatibility	Complies with all ISO10993-1 required testsfor absorbable surgicalsutures	Complies with all ISO10993-1 required testsfor absorbable surgicalsutures	Same
Packaging	Validated sterile barrierpackaging system	Validated sterile barrierpackaging system	Same

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Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence:

The below referenced testing demonstrated substantial equivalence of the CARESORB® - Polyglactin 910 Surgical Suture and CARESORB® RAPID -Polyglactin 910 (fast absorbing) Surgical Suture to the Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide predicate devices respectively. The testing was conducted on the final sterilized devices in accordance with the FDA Class II Special Controls Guidance Document: Surgical Sutures.

Performance Testing:

1. ISO 10993-3 Biological Evaluation of Medical Devices Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity, 2014
1. ISO 10993-5 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity, 2009 (R) 2014
1. ISO 10993-6 Biological Evaluation of Medical Devices Part 6: Tests for Local Effects after Implantation, 2007 (R) 2014
1. ISO 10993-7 Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterilization Residuals, 2008 (R) 2012
1. ISO 10993-10 Biological Evaluation of Medical Devices Part 10: Tests for Irritation and Skin Sensitization, 2010 (R) 2014

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1. ISO 10993-11 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity, 2006 (R) 2010
1. USP 39-NF33 Absorbable Surgical Suture, 2016
1. USP 39-NF33 <861> Sutures Diameter, 2016
1. USP 39-NF33 <871> Sutures Needle Attachment, 2016
1. USP 39-NF33 <881> Tensile Strength, 2016
1. ISO 11607-1 Section 5.2 Whole package microbial aerosol challenge test, 2014
1. ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials, 2015
1. ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages, 2013
1. ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test), 2011
1. USP39-NF 34 <71> Sterility Test, 2016
1. USP39-NF 34 <85> Bacterial Endotoxins Test, 2016
1. ISO 15223-1 Third Edition 2016-11-01, Medical Devices Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements. (General I (QS/RM))

The biocompatibility test results demonstrated no evidence of cytotoxicity, irritation, delayed dermal sensitization or acute systemic toxicity for CARESORB® Surgical Suture. In the short-term, mid-term and long-term Intramuscular Implantation Tests with Histopathology, the CARESORB® Surgical Suture was considered a non-irritant as compared to the predicate VICRYL™ used as a control. In the mid-term Intramuscular Implantation Test with Histopathology, the CARESORB® Rapid Surgical Suture was considered a non-irritant as compared to the predicate VICRYL™ Rapide used as a control.

The CARESORB® Suture was also found to be non-pyrogenic, non-mutagenic and non-genotoxic.

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Resorption Profile:

The resorption profiles of the final sterilized sutures were demonstrated in vivo.

The CARESORB® sutures were compared to the predicate VICRYL™ sutures in the in-vivo implantation study. The study results demonstrated that CARESORB® sutures have similar tensile strength retention profile in comparison to the marketed predicate VICRYL™ sutures.

The in-vivo breaking strength retention profile of CARESORB® RAPID was based on the data provided by the suture material supplier from the in-vivo implantation study. The resorption profile of CARESORB® RAPID was determined to be similar to that of the marketed predicate VICRYL™ Rapide.

The resorption profile of the final sterilized CARESORB® RAPID suture was also demonstrated in vitro.

The CARESORB® RAPID. sterilized by EtO. were compared to the predicate VICRYL™ Rapide sutures, sterilized by gamma irradiation, and to the raw material supplier's sutures, sterilized by gamma irradiation. All sutures were immersed in the phosphate buffer solution (pH 7.4) for 5. 14. 21 and 28 days and then tested for breaking strength retention at each time point. The study results demonstrated that all three sutures had essentially identical resorption profiles under the same study conditions and that tensile strength and tensile strength retention of CARESORB® RAPID was comparable to those of VICRYL™ Rapide and the raw material supplier's sutures.

Additionally, the rate of absorption of CARESORB® sutures was compared to that of predicate VICRYL™ sutures in the in-vivo implantation study. The study results demonstrated that CARESORB® sutures and VICRYL™ sutures have very similar absorption in tissue.

The rate of absorption of CARESORB® RAPID was based on the data provided by the suture material supplier from the in-vivo implantation study. The CARESORB RAPID rate of absorption in tissue was determined to be similar to that of the marketed predicate VICRYL™ Rapide.

Shelf Life:

CARESORB® and CARESORB® RAPID sutures have been tested in real time stability studies as well as in the accelerated aging studies.

The real time stability studies for both sutures were performed at 18°C to 26°C temperature and relative humidity of no more than 65%. The accelerated aging stability studies were performed at 68°C to 72°C temperature and relative humidity of no more than 65% for CARESORB® and at 53°C to 57°C temperature and relative humidity of no more than 65% for CARESORB® RAPID.

The aged sutures were tested for parameters specified in the USP Monograph for Absorbable Surgical Sutures and other applicable requirements:

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Diameter, USP 39 <861>
Needle Attachment, USP 39 <871> ●
Tensile Strength, USP 39 <881> ●
In vitro Breaking Strength Retention (BSR)
Visual Inspection ●
. Moisture content
Sterility Testing, USP 39-NF34 <71> ●

The study results demonstrated conformance to the specified acceptance criteria and supported the 5 year expiration date assignment for CARESORB® and CARESORB® RAPID sutures.

8. Discussion of Clinical Tests Performed:

Not Applicable

9. Conclusions:

The CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 Surgical Sutures are composed of the same material, have the same intended use and main technological characteristics as their respective predicate devices Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide Surgical Sutures.

Based on the results of completed performance testing inclusive of physical testing, biocompatibility testing and absorption profile, it can be concluded that CARESORB® - Polyglactin 910 and CARESORB® RAPID - Polyglactin 910 are substantially equivalent in terms of safety and effectiveness to Ethicon's Coated VICRYL™ and Ethicon's Coated VICRYL™ Rapide respectively.

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(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.