(141 days)
The MANI Needle & Suture Pack (Silk) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
The MANI Needle & Suture Pack (Silk) consists of a stainless steel needle and silk suture, for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
This document is a 510(k) summary for a medical device called the "MANI Needle and Suture Pack (Silk)". It's a regulatory submission to the FDA, not a study report. Therefore, it does not contain the detailed information about acceptance criteria and a study proving device performance as requested.
The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing performance metrics from a dedicated clinical or analytical study.
Here's an analysis of what information could be extracted or inferred based on the provided text, and what information is explicitly missing:
Missing Information:
The provided text does not contain any of the requested information regarding specific acceptance criteria for performance or details of a study (clinical or analytical) to prove those criteria are met. This document is a regulatory summary for a 510(k) submission, which aims to demonstrate "substantial equivalence" to a predicate device, as opposed to proving novel clinical endpoints or detailed performance characteristics with a dedicated study.
Explanation Based on the Document Type:
510(k) submissions, like this one, typically rely on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device that is already legally on the market. This often involves:
- Comparison to Predicate Device: The document clearly states the predicate device: "Alcon Laboratories Needles and Sutures, 510(k) # 760158." The conclusion states, "MANI, Inc. believes that the MANI Needle & Suture Pack (Silk) is substantially equivalent to its claimed predicates under conditions of intended use." This comparison is the primary "proof" for a 510(k).
- Intended Use Statement: The "Indications for Use" section outlines what the device is for ("short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue"). The substantial equivalence argument means that if the predicate device is safe and effective for this use, and the new device is substantially similar, then the new device is also considered safe and effective for the same use.
Therefore, the questions you've asked about acceptance criteria, study details, sample sizes, experts, ground truth, and specific performance metrics are not typically found in this type of 510(k) summary unless a specific performance test was required to establish substantial equivalence for a particular attribute.
The document implies that the device "meets the acceptance criteria" in the sense that the FDA found it substantially equivalent to its predicate, which is the regulatory "acceptance criterion" for a 510(k) clearance. However, this is not performance acceptance criteria as would be found in a clinical trial or engineering performance verification.
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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 (Silk) 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-MachiTochigi 329-1234 Japan (Headquarters) |
| Contact Person: | David J. BlochRegulatory Counsel |
| Telephone: | (202) 414-9209 (telephone)(202) 414-9209 (fax) |
| Preparation Date: | January 2005 |
| Device Trade Name: | MANI Needle and Suture Pack (Silk) |
| Common Name: | Guide Needle, Surgical; Non-Absorbable Suture, Silk. |
| Classification Name: | Guide Needle, Surgical; (see 21 C.F.R. § 878.4493)Non-Absorbable Suture, Silk(21 C.F.R. § 878.5030)Product Code: GAP |
| Predicate Devices: | Alcon Laboratories Needles and Sutures, 510(k) # 760158. |
| Device Description: | The MANI Needle & Suture Pack (Silk) consists of astainless steel needle and silk suture, for use in short termsoft tissue approximation, including use in ophthalmicsurgery, but not for use in cardiovascular and neurologicaltissue. |
| Intended Use: | The MANI Needle & Suture Pack (Silk) is intended for use inshort term soft tissue approximation, including use in |
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ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
CONCLUSIONS: Based on the foregoing and other information in this application, MANI, Inc. believes that the MANI Needle & Suture Pack (Silk) is substantially equivalent to its claimed predicates under conditions of intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 9 2006
MANI, Inc. % ReedSmith Mr. David J. Bloch, Esq. 1301 K. Street, NW Suite 1100 - East Tower Washington, District of Columbia 20005-3373
Re: K053638
Trade/Device Name: MANI Needle & Suture Pack (Silk) Regulation Number: 21 CFR 878.5030 Regulation Name: Natural nonabsorbable silk surgical suture Regulatory Class: II Product Code: GAP Dated: April 24, 2006 Received: April 26, 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
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Page 2 - Mr. David J. Bloch, Esq.
forth in the quality systems (OS) 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 Office of Compliance at (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Milliken
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 (if known):
Device Name: MANI Needle & Suture Pack (Silk)
Indications For Use:
大きなくている人気をなると、同時のためますが、
The MANI Needle & Suture Pack (Silk) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
the state the the production of the season of the state of the collection of the comments of
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)
Herbert Lemer no
(Division Sign-Division of General, Restorative, and Neurological Devices
510(k) Number K053638
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
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 speciesBombyx mori (B. mori ) of the familyBombycidae. 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.(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.