Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

Absorbable Polydioxanone Suture with Needle is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.

Device Description

The applicant devices of absorbable polyglycolic acid suture with needle consist of a polyglycolic acid surgical suture made of polyglycolic acid and a stainless steel needle. It is EO sterilized, and prygon-free.

The applicant devices of absorbable polydioxanone suture with needle consist of a polydioxanone surgical suture made of polyester and a stainless steel needle. It is unbraided. It is EO sterilized, and prygon-free.

AI/ML Overview

The document describes the acceptance criteria and supporting studies for two types of absorbable surgical sutures with needles: Absorbable Polyglycolic Acid Suture with Needle and Absorbable Polydioxanone Suture with Needle.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list "acceptance criteria" with numerical targets and then "reported performance" against those targets in a table format. Instead, it states that performance data was collected in accordance with recognized standards, implying that meeting these standards constitutes the acceptance criteria.

Absorbable Polyglycolic Acid Suture with Needle & Absorbable Polydioxanone Suture with Needle (both devices)

Acceptance Criteria Category	Standard/Test Performed	Reported Device Performance
Physical Properties	USP 30, <861> Suture Diameter	Demonstrated compliance with USP 30 for suture diameter. (Implied: met requirements)
	USP 30, <871> Suture Attachment	Demonstrated compliance with USP 30 for suture attachment. (Implied: met requirements)
	USP 30, <881> Tensile Strength	Demonstrated compliance with USP 30 for tensile strength. (Implied: met requirements)
Biocompatibility	ISO 10993	Biocompatibility studies were performed in accordance with ISO 10993. (Implied: met requirements)
In Vivo Strength/Degradation	In vivo strength test	Conducted to demonstrate rates of tensile and mass loss. (Implied: met requirements for intended dissolution profile)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for any of the tests (physical, biocompatibility, or in vivo strength).
The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the studies are focused on material properties and biocompatibility, not diagnostic interpretations requiring expert ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for material performance testing.

5. 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for diagnostic or AI-assisted interpretation devices, not for surgical sutures.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is a surgical suture, not an algorithm or AI-driven system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance testing of these sutures is established through predefined, standardized test methods and specifications (e.g., USP 30, ISO 10993) which define the acceptable range or characteristics of the material. For in-vivo testing, it would be direct measurement of tensile strength and mass loss over time.

8. The sample size for the training set

This information is not applicable as the device is a manufactured medical product, not a machine learning model that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable for the same reason as above.

Summary

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K073614 page 1/3

Premarket Notification 510(k) Submission -510(k) Summary Report No .: A20071012

APR 3 0 2008

510(k) Summary

As Required by 21 CFR 807.92

The Assigned 510(k) Number is: K073614

Submitter Information:

Manufacturer Name: Foosin Medical Supplies Inc., Ltd. No.312, Shichang Road Weihai, Shandong, China, 264209

Contact Person of the Submission: Ms. Diana Hong Mr. Eric Chen Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road Shanghai, China 20020 Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong(@mid-link.net eric.chen(a)mid-link.net

Applicant Device Information

Absorbable Polyglycolic Acid Suture with Needle

1.1 Applicant Device Information

Trade/Proprietary Name: WG-Surgical Sutures with Needle Common Name: Absorbable Polyglycolic Acid Suture with Needle Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid Device Class: II Product Code: GAM Regulation Number: 878.4493 Review Panel: General & Plastic Surgery

Shanghai Mid-Link Business Consulting Co., Ltd

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K073614 p

Premarket Notification 510(k) Submission -510(k) Summary Report No .: A20071012

Intended Use:

Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

1.2Predicate Device

K-number: K063536

1.3Device Description

1.4 Performance Data:

Physical testing was performed on the subject device to USP 30, including <861> Suture Diameter, <871> Suture Attachment, <881> Tensile Strength. Biocompatibility studies were performed in accordance with ISO10993. In vivo strength test was also conducted on the subject device to demonstrate rates of tensile and mass loss.

1.5 Substantially Equivalence Determination

The applicant device of Absorbable Polyglycolic Acid Suture with Needle is substantially equivalent to the predicate device.

2. Absorbable Polyglycolic Acid Suture with Needle

2.1Applicant Device Information

Trade/Proprietary Name: WG-Surgical Sutures with Needle Common Name: Absorbable Polydioxanone Suture with Needle Classification Name: Suture, Absorbable, Synthetic, Polydioxanone Device Class: II Product Code: NEW Regulation Number: 878.4840 Review Panel: General & Plastic Surgery Intended Use:

2.2Predicate Device

K-number: K053380

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K073614

2.3Device Description

2.4 Performance Data:

2.5 Substantially Equivalence Determination

The applicant device of Absorbable Polydioxanone Suture with Needle is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 3 0 2008

Foosin Medical Supplies, Inc. % Shanghai Midlink Business Consulting Co., Ltd. Ms. Diana Hong Suite 8D, Zhongxin Zhongshan Mansion No. 19, Lane 999, Zhong Shan No. 2 Road(S) Shanghai, China 200030

Re: K073614

Trade/Device Name: WG-Surgical Sutures with Needle Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW, GAM Dated: April 4, 2008 Received: April 4, 2008

Dear Ms. Hong:

We have reviewed vour 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Diana Hong

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket survéillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K073614

WG-Surgical Sutures with Needle Device Name:

Indications for Use:

Absorbable polyglycolic acid suture with needle is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, cardiovascular and neurological tissues.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil Rr Ggl for AKm
(Division Sign-Off)

Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number K073614

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.