MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)

K053636 · Mani, Inc. · GAM · Mar 14, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K053636
• Device Name: MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE)
• Applicant: Mani, Inc.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Mar 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MANI Needle & Suture Pack (PGA Absorbable) is intended for use in short term soft tissue approximation. including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

Device Story

Device consists of stainless steel needle and PGA (polyglycolic acid) absorbable suture. Used by surgeons for short-term soft tissue approximation; includes ophthalmic applications. Excludes cardiovascular and neurological tissue. Device functions as a mechanical tool for wound closure; no electronic or software components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Stainless steel needle, PGA (polyglycolic acid) absorbable suture. Form factor: Needle and suture pack. Sterilization: Not specified. No electronic, software, or energy-based components.

Indications for Use

Indicated for short-term soft tissue approximation, including ophthalmic surgery. Contraindicated for cardiovascular and neurological tissue.

Regulatory Classification

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.

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

• Surgisorb Absorbable PGA Sutures (K984374)

Submission Summary (Full Text)

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## MAR 1 4 2006

## 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 (PGA Absorbable) 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 (PGA Absorbable) |
| Common Name: | Guide Needle, Surgical; Non-<br>Absorbable Suture, PGA Absorbable. |
| Classification Name: | Guide Needle, Surgical; (see 21 C.F.R. § 878.4800)<br>Non-Absorbable Suture, PGA Absorbable<br>(21 C.F.R. § 878. 878.4493)<br>Product Code: GAM |
| Predicate Devices: | Surgisorb Absorbable PGA Sutures, 510(k) # 984374. |
| Device Description: | The MANI Needle & Suture Pack (PGA Absorbable) consists<br>of a stainless steel needle and PGA Absorbable suture, for<br>use in short term soft tissue approximation, including use in<br>ophthalmic surgery, but not for use in cardiovascular and<br>neurological tissue. |

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| Intended Use: | The MANI Needle & Suture Pack (PGA Absorbable) is<br>intended for use in short term soft tissue approximation.<br>including use in ophthalmic surgery, but not for use in<br>cardiovascular and neurological tissue. |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONCLUSIONS: | Based on the foregoing and other information in this<br>application, MANI, Inc. believes that the MANI Needle &<br>Suture Pack (PGA Absorbable) is substantially equivalent to<br>its claimed predicates under conditions of intended use. |

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAR 1 4 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MANI. Inc. c/o ReedSmith Mr. David J. Bloch, Esq. Regulatory Counsel 1301 K Street, N.W. Suite 1100 - East Tower Washington, District of Columbia 20005-3373

Re: K053636

Trade/Device Name: MANI Needle & Suture Pack (PGA Absorbable) Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable poly(glycolide/L .- lactide) surgical Regulatory Class: II Product Code: GAM Dated: February 27, 2006 Received: March 1, 2006

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) I mis letter will and w yourse 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 if you active 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

l-mee

m 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

510(k) Number (if known):

Device Name: MANI Needle & Suture Pack (PGA Absorbable)

Indications For Use:

The MANI Needle & Suture Pack (PGA Absorbable) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.

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)

elqml

Division of General, Restorative. and Neurological Devices

510(k) Number_ K053636