WG-SURGICAL SUTURES WITH NEEDLE

K080684 · Foosin Medical Supplies, Inc. · GAP · Jun 9, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080684
• Device Name: WG-SURGICAL SUTURES WITH NEEDLE
• Applicant: Foosin Medical Supplies, Inc.
• Product Code: GAP · General, Plastic Surgery
• Decision Date: Jun 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. Nonabsorbable Polypropylene Suture with Needle is indicated for use in soft tissue approximation and/or ligation including use in general cardiovascular, ophthalmic and neurological procedures. Nonabsorbable Polyester Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures. Nonabsorbable Polyamide suture with needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures.

Device Story

WG-Surgical Sutures with Needle consist of nonabsorbable surgical suture material (silk, polypropylene, polyester, or polyamide) attached to a stainless steel needle. Used by surgeons for soft tissue approximation and ligation in clinical settings. Devices are EO sterilized and pyrogen-free. Sutures provide mechanical closure of tissue; needle facilitates passage through tissue. Benefit is secure wound closure.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Nonabsorbable surgical sutures (silk, polypropylene, polyester, polyamide) with stainless steel needles. Braided silk; synthetic polymers for others. EO sterilized. Standalone manual surgical instruments.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in cardiovascular, ophthalmic, and neurological procedures (polyamide limited to general and ophthalmic). Prescription use only.

Regulatory Classification

Identification

Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori ) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

Special Controls

*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.

Predicate Devices

• Silk Suture (K041514)
• Polypropylene Suture (K070243)
• Polyester Suture (K060165)
• Polyamide Suture (K0060471)

Submission Summary (Full Text)

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# 510(k) Summary

As required by section 807.92(c)

JUN - 9 2008

The Assigned 510(k) Number is:

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: [phone] x 152 Fax: [phone] x 809 Email: Diana.hong(@mid-link.net eric.chen(@)mid-link.net

#### Subject Device Information

- Nonabsorbable Silk Suture with Needle 1.
# 1.1 Applicant Device Information

Trade/Proprietary Name: WG-Surgical Sutures with Needle Common Name: Nonabsorbable Silk Suture with Needle Classification Name: Suture, Nonabsorbable, Silk Device Class: II Product Code: GAP Regulation Number: 878.5030 Review Panel: General & Plastic Surgery Intended Use: Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation

Shanghai Mid-Link Business Consulting Co., Ltd

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and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

#### 1.2Predicate Device

#### K-number: K041514

# 1.3 Device Description

The applicant devices of nonabsorbable silk suture with needle consist of a silk surgical suture made of natural silk and a stainless steel needle. It is EO sterilized, and prygon-free. Nonabsorbable silk suture is braided.

#### 1.4 Substantially Equivalence Determination

The applicant device of nonabsorbable silk surgical suture is substantially equivalent to the predicate device.

#### 2. Nonabsorbable Polypropylene Suture with Needle

### 2.1Applicant Device Information

Trade/Proprietary Name: WG-Surgical Sutures with Needle Common Name: Nonabsorbable Polypropylene Suture with Needle Classification Name: Suture, Nonabsorbable, Synthetic, Polypropylene Device Class: II Product Code: GAW Regulation Number: 878.5010 Review Panel: General & Plastic Surgery Intended Use:

Nonabsorbable Polypropylene Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

#### 2.2Predicate Device

K-number: K070243

#### 2.3Device Description

The applicant devices of nonabsorbable polypropylene suture with needle consist of a silk surgical suture made of polypropylene and a stainless steel needle. It is EO sterilized, and prygon-free.

### 2.4Substantially Equivalence Determination

The applicant device of Nonabsorbable polypropylene Suture with Needle is substantially equivalent to the predicate device.

## 3. Nonabsorbable Polyester Suture with Needle

Shanghai Mid-Link Business Consulting Co., Ltd

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#### 3.1Applicant Device Information

Trade/Proprietary Name: WG-Surgical Sutures with Needle Common Name: Nonabsorbable Polyester Suture with Needle Classification Name: Suture, Nonabsorbable, Synthetic, Polyethylene Devicc Class: Il Product Code: GAT Regulation Number: 878.5000 Review Panel: General & Plastic Surgery Intended Use: Nonabsorbable Polyester Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

#### 3.2Predicate Device

K-number: K060165

#### 3.3Device Description

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

# 3.4Substantially Equivalence Determination

The applicant device of Nonabsorbable Polyester Suture with Needle is substantially equivalent to the predicate device.

## 4.Nonabsorbable Polyamide Suture with Needle

#### 4.1Applicant Device Information

Trade/Proprietary Name: WG-Surgical Sutures with Needle Common Name: Nonabsorbable Polyamide Suture with Needle Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide Devicc Class: II Product Code: GAR Regulation Number: 878.5020 Review Panel: General & Plastic Surgery Intended Use: Nonabsorbable Polyamide suture with needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures.

#### 4.2Predicate Device

K-number: K0060471

#### 4.3Device Description

Shanghai Mid-Link Business Consulting Co., Ltd

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The applicant devices of nonabsorbable polyamide suture with needle consist of a polyamide surgical suture made of long-chain, aliphatic polymers nylon and a stainless steel needle. It is EO sterilized, and prygon-free.

# 4.4Substantially Equivalence Determination

The applicant device of nonabsorbable polyamide suture with necdle is substantially equivalent to the predicate device.

#### Shanghai Mid-Link Business Consulting Co., 1.td

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2008

Foosin Medical Supplies Inc. % Shanghai Midlink Business Consulting Co., Ltd. Ms. Diana Hong Suite 8D, Zhongxin Zhongshan Mansion No. 19, Lane 999, Zhongshan No. 2 Road (S) Shanghai 20030 China

Re: K080684

Trade/Device Name: Nonabsorbable Silk Suture with Needle, Nonabsorbable Polypropylene Suture with Needle, Nonabsorbable Polyester Suture with Needle, Nonabsorbable Polyamide suture with needle Regulation Number: 21 CFR 878.5030 Regulation Name: Natural nonabsorbable silk surgical suture Regulatory Class: II Product Code: GAP, GAW, GAT, GAT, GAR Dated: May 2, 2008 Received: May 5, 2008

Dear Ms. Hansen:

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.

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.

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Page 2 -- Ms. Peggy Hansen, RAC

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 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 [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Milliman

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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K080654 1/4

510(k) Number:_

Device Name: ___ Nonabsorbable Silk Suture with Needle

Indications for Use:

Nonabsorbable Silk Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular , ophthalmic and neurological procedures.

Prescription Use √ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Neil R.P. Johnson for San

Page 1 of 4

Division of General, Restorative, and Neurological Devices

510(k) Number.

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12080684 2/4

Device Name: __ Nonabsorbable Polypropylene Suture with Needle

Indications for Use:

Nonabsorbable Polypropylene Suture with Needle is indicated for use in soft tissue approximation and/or ligation including use in general cardiovascular, ophthalmic and neurological procedures.

Prescription Use __ J (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use . (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)

Neil Rl. Ogden for mxa

Page 2 of 4

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number KD80684

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1000684314

510(k) Number:***_***_

080684

Device Name:

Indications for Use:

Nonabsorbable Polyester Suture with Needle is indicated for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

Prescription Use _ V (Part 21 CFR 801 Subpart D)

. AND/OR

Over-The-Counter Use (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)

Mut. R.P. Ogle for M
St. Ogle

Page 3 of 4

Division of General, Restorative and Neurological Devices

510(k) Number

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Premarket Notification 510(k) Submission—Indications for Use
Report No.: A20071012

080684 510(k) Number:

Device Name:

Indications for Usc:

Nonabsorbable Polyamide suture with needle is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures.

Prescription Use __ イ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Page 4 of 4

Neifredgalan fr mxm

Division of General and Neurological Devices

510(k) Number K080684