(141 days)
The MANI Needle & Suture Pack (Nylon) 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 (Nylon) consists of a stainless steel needle and Nylon 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 the MANI Needle and Suture Pack (Nylon), a medical device. It describes the device, its intended use, and claims substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving it:
This document does not contain the information you are requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria."
This 510(k) submission is a declaration of substantial equivalence to an already legally marketed device (a predicate device). For this type of submission, the manufacturer typically demonstrates that their new device is as safe and effective as the predicate device by showing it has the same intended use, technological characteristics, and performs similarly through direct comparison, not by conducting new clinical studies or defining new acceptance criteria for the device.
Therefore, I cannot populate your table or answer the specific questions because the provided text does not include:
- A table of acceptance criteria and reported device performance.
- Details of a study proving the device meets acceptance criteria.
- Information about sample sizes for test sets or training sets.
- Data provenance, number or qualifications of experts, or adjudication methods for ground truth.
- Any mention of MRMC comparative effectiveness studies or standalone algorithm performance.
- Description of the type of ground truth used.
Instead, the document focuses on:
- Device Description: What the MANI Needle and Suture Pack (Nylon) is made of (stainless steel needle and Nylon suture).
- Intended Use: For short-term soft tissue approximation, including ophthalmic surgery, but not for cardiovascular and neurological tissue.
- Predicate Device: Alcon Laboratories, Surgical Suture, 510(k) # 930517.
- Conclusion: The device is substantially equivalent to its claimed predicates under conditions of intended use.
- FDA Clearance: The FDA letter confirms the device is substantially equivalent and can be marketed.
In summary, for a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device, and the "study" is often a comparison of technical specifications and performance data (which is not detailed here beyond the claim of equivalence) rather than a novel clinical trial with pre-defined acceptance metrics.
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K053637
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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 (Nylon) 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 (Nylon) |
| Common Name: | Guide Needle, Surgical; Non-Absorbable Suture, Nylon. |
| Classification Name: | Guide Needle, Surgical; (see 21 C.F.R. § 878.4493)Non-Absorbable Suture, Nylon(21 C.F.R. § 878.5020) |
| Product Code: GAR | |
| Predicate Devices: | Alcon Laboratories, Surgical Suture, 510(k) # 930517. |
| Device Description: | The MANI Needle & Suture Pack (Nylon) consists of astainless steel needle and Nylon suture, for use in short termsoft tissue approximation, including use in ophthalmicsurgery, but not for use in cardiovascular and neurologicaltissue. |
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Intended Use:
CONCLUSIONS:
The MANI Needle & Suture Pack (Nylon) is intended for use in short term soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue.
Based on the foregoing and other information in this application, MANI, Inc. believes that the MANI Needle & Suture Pack (Nylon) is substantially equivalent to its claimed predicates under conditions of intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 19 2006
MANI, Inc. % ReedSmith Mr. David J. Bloch, Esq. 1301 K. Street, NW Suite 1100 - East Tower Washington, District of Columbia 20005-3373
Re: K053637
Trade/Device Name: MANI Needle & Suture Pack (Nylon) Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: II Product Code: GAR 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 (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 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,
Hubert Remmers
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
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保障の原因を家庭和社会
510(k) Number (if known):
Device Name: MANI Needle & Suture Pack (Nylon)
Indications For Use:
The station of the state of the state of the states of the states and the
The MANI Needle & Suture Pack (Nylon) 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)
Helmut Lerner
Division of General, Restorative. and Neurological Devices
Kos3677 510(k) Number_
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; 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.(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.