MANI NEEDLE & SUTURE PACK

K050150 · Mani, Inc. · GAT · Dec 5, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050150
• Device Name: MANI NEEDLE & SUTURE PACK
• Applicant: Mani, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Dec 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery.

Device Story

The MANI Needle & Suture Pack consists of a stainless steel surgical needle and a poly(ethylene terephthalate) suture. It is used by surgeons in clinical settings, including ophthalmic surgery, for short-term soft tissue approximation. The device is provided as a sterile pack. The surgeon uses the needle to pass the suture through tissue to approximate edges, facilitating healing. The device functions as a standard surgical tool for wound closure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel needle; poly(ethylene terephthalate) suture; sterile; manual surgical instrument; non-absorbable.

Indications for Use

Indicated for short term soft tissue approximation, including ophthalmic surgery, in patients requiring surgical closure.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

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

• CP Medical, Orthofiber, 510(k) # 041894

Submission Summary (Full Text)

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K050150
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soft

## DEC 5 2005

## 510(k) SUMMARY MANI Needle and Suture Pack MANI, Inc.

This 510(k) summary of safety and effectiveness for the MANI Needle and Suture Pack (Poly(ethylene terephthalate)) is submitted in accordance with the requirements of SMDA and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

| Applicant: | MANI, Inc. |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 743 Nakaakutsu Takanezawa-Machi<br>Tochigi 329-1234 Japan (Headquarters) |
| Contact Person: | David J. Bloch<br>Regulatory Counsel |
| Telephone: | [phone] (telephone)<br>[phone] (fax) |
| Preparation Date: | January 2005 |
| Device Trade Name: | MANI Needle and Suture Pack (Poly(ethylene<br>terephthalate)) |
| Common Name: | Guide Needle, Surgical; Non-<br>Absorbable Suture, Poly(ethylene terephthalate). |
| Classification Name: | Guide Needle, Surgical; (see 21 C.F.R. § 878.4493)<br>Non-Absorbable Suture, Poly(ethylene terephthalate)<br>(21 C.F.R. § 878.5000)<br>Product Code: GAT |
| Predicate Devices: | CP Medical, Orthofiber, 510(k) # 041894; |
| Device Description: | The MANI Needle & Suture Pack (Poly(ethylene<br>terephthalate)) consists of a stainless steel needle and<br>poly(ethylene terephthalate) suture, for use in short term<br>tissue approximation, including use in ophthalmic surgery. |

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K050/50
page 292

The MANI Needle & Suture Pack (Poly(ethylene Intended Use: terephthalate)) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery.

Based on the foregoing and other information in this CONCLUSIONS: application, MANI, Inc. believes that the MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is substantially equivalent to its claimed predicates under conditions of intended use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized emblem. The emblem consists of a symbol that resembles a stylized caduceus, a traditional symbol of medicine, with three parallel lines forming a wing-like shape.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2005 DEC 5

Mani, Inc. c/o David J. Bloch, Esq. Regulatory Counsel Reed Smith, LLP 1301 K Street, N.W. Suite 1100-East Tower Washington, D.C. 20005-3373

Re: K050150

Trade/Device Name: MANI Needle & Suture Pack (Poly(ethylene terephthalate)) Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, GDL Dated: November 9, 2005 Received: November 9, 2005

Dear Mr. Bloch:

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.

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.

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Page 2- David J. Bloch, Esq.

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours

Mark N. Melkerson Acting 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

Kosol 50 510(k) Number (if known):

Device Name: MAN! Needle & Suture Pack (Poly(ethylene terephthalate))

Indications For Use:

The MANI Needle & Suture Pack (Poly(ethylene terephthalate)) is intended for The MANI Needle & Suture Fack (F Sty(Stryton) Corp.
use in short term soft tissue approximation, including use in ophthalmic surgery.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchund

al, Restorative. and Neurological Devices

51000 Number K050150