(132 days)
The NeoTract Anchor is intended for the approximation of tissue in open surgical procedures.
The NeoTract Anchor is intended for the approximation of soft tissue in open surgical procedures.
The NeoTract Anchor is designed to approximate tissue following open surgical procedures.
This submission (K061700) refers to a 510(k) Premarket Notification for the NeoTract Anchor, a surgical device intended for tissue approximation. The provided text, however, does not contain a study that presents acceptance criteria and reported device performance in the way typically expected for an AI/ML device.
This document describes a medical device called the "NeoTract Anchor" which is a physical surgical device (a staple/anchor for tissue approximation), not an AI/ML software device. The "Testing Summary" section notes that "Simulated use and performance testing was conducted on the NeoTract Anchor and compared to the predicate device, Onux Salute," and that "All components, subassemblies, and/or full devices met the required specifications for the completed tests." However, it does not provide the quantitative or qualitative details of these tests, or the specific acceptance criteria.
Therefore, I cannot fulfill your request for information related to an AI/ML device's acceptance criteria and studies, as this document is not about such a device. The information requested (sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specifically relevant to the evaluation of AI/ML algorithms and is not addressed in this 510(k) submission for a physical surgical anchor.
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K061700 10/26/06
510(k) Premarket Notification
NeoTract Anchor
NeoTract, Inc.
TAB 4
Page 1 of 1
510(k) Summary
NeoTract Anchor (REF 10230-01)
General Information
Classification Class II, Surgical Staple per 21 CFR § 878.4750
Trade Name
Submitter
NeoTract, Inc. 4473 Willow Road, Suite 100 Pleasanton, CA 34588
Tel. 415 609 9875
Contact
Kevin F. MacDonald Regulatory Consultant
Intended Use
The NeoTract Anchor is intended for the approximation of tissue in open surgical procedures.
Predicate Devices
Onux Salute Stapler and Staples - K003522 (Davol® Salute® Fixation System)
Device Description
The NeoTract Anchor is designed to approximate tissue following open surgical procedures.
Materials
The materials used in the manufacture of the NeoTract Anchor are well-characterized implant materials and are suitable for this use. The materials have been used in previously cleared products.
Testing Summary
Simulated use and performance testing was conducted on the NeoTract Anchor and compared to the predicate device, Onux Salute (Davol® Salute® Fixation System). All components, subassemblies, and/or full devices met the required specifications for the completed tests. The NeoTract Anchor was designed under the NeoTract Quality System that is in complive to with 21CFR§820.30.
Summary of Substantial Equivalence
The NeoTract Anchor is substantially equivalent to the predicate device, the Onux Salute (Davol® Salute® Fixation System). The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. Nec Tract, Inc. believes the NeoTract Anchor is substantially equivalent to existing legally marketed devices.
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Image /page/1/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 a stylized symbol that resembles a human figure embracing a three-barred wave-like shape. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 26 2006
NeoTract, Inc. % Mr. Kevin F. MacDonald Clinical/Regulatory Consultant 4473 Willow Road, Suite 100 Pleasanton, California 94588
Re: K061700
Trade/Device Name: NeoTract Anchor (REF 10230-01) Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW, GDW, Dated: October 11, 2006 Received: October 12, 2006
Dear Mr. MacDonald:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Bection 510(x) presidentially equivalent (for the indications for referenced above and nave acterially marketed predicate devices marketed in interstate commerce use stated in the enerobare) to region date of the Medical Device Amendments, or to devices that prior to May 20, 1970, and cordance with the provisions of the Federal Food, Drug, and Cosmetic have oven rectablines in approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general thereolor, mailier the device, dables requirements for annual registration, listing of devices, good controls provisions of the many and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassimod (600 above) and existing major regulations affecting your device can Inay be subject to such additional venusions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r least of advised that i Dris issuanted evour device complies with other requirements of the Act that 1177 has mudes and regulations administered by other Federal agencies. You must comply or any I catal statues are regalized ing, but not limited to: registration and listing (21 CFR Part with an the Act 3 requirements, merading oursective requirements as set forth in the 807); fabeting (21 OF R Part 820); and if applicable, the electronic product and radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Kevin F. MacDonald
This letter will allow you to begin marketing your device as described in your Section 510(k)
I has and the market of the same of the spirales of your device to a legal This letter will allow you to begin maketing your dovice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivalence of the premarket notification. The PDA michig of substantial of 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
rst lead If you desire specific advice for your device at (240) 276-0115. Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0115. Also, please n contact the Office of Compliance at (2107278 of 107.97). You may obtain other
"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 general information on your responsibilities and its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistanto artist of the real of the new of thindustry/support/index.html.
Sincerely yours,
K. N. Mellem
Mark N. Melkerso Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Response to FDA - October 22, 2006 Neo'fract, Inc. K061700 - NeoTract Anchor
Indications for Use
K061700 510(k) Number (if known):
Device Name:
NeoTract Anchor (REF 10230-01)
Indications for Use:
The NeoTract Anchor is intended for the approximation of soft tissue in open surgical procedures.
Prescription Use X
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Page 1 of 1
3
CONFIDENTIAL
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene 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 undyed or dyed with an FDA approved color additive; and 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.