(72 days)
Not Found
No
The summary describes a mechanical tissue approximation system and does not mention any AI or ML components or functions.
No
The device is described as being for "approximation of tissue in open surgical procedures," which is a surgical tool function, not an active treatment or therapy.
No
The device is described as an "Anchor System" intended for "approximation of tissue in open surgical procedures," which points to a therapeutic or surgical function rather than a diagnostic one.
No
The device description explicitly states it consists of a delivery device with a handle, trigger assembly, and stainless steel shaft, and delivers a permanently implanted Suture Anchor, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the approximation of tissue in open surgical procedures." This describes a surgical tool used directly on a patient's body during a procedure.
- Device Description: The description details a delivery system and a permanently implanted Suture Anchor, again indicating a surgical device used in vivo (within a living organism).
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any interaction with such specimens or any diagnostic purpose.
Therefore, the Modified NeoTract Anchor System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Modified NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.
Product codes
GAT, GDW
Device Description
The Modified NeoTract Anchor System is used for the approximation of soft tissue in open surgical procedures. It consists of a single use delivery device that delivers the permanently implanted Suture Anchor. The delivery system is comprised of a polycarbonate handle and trigger assembly connected to a stainless steel shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open surgical procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
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.(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.
0
| 4. 510(k) Summary
| General Information | ||||
|---|---|---|---|---|
| Date Compile | April 30, 2010 | JUL 15 2010 | ||
| Classificatior | 21 CFR 878.5000, Nonabsorbable Polyethylene Terephthalate Surgica | |||
| Suture | ||||
| Product code GAT, GDW | ||||
| Trade Name | Modified NeoTract Anchor System | |||
| Common | ||||
| Name | Surgical Suture | |||
| Submitter | NeoTract, Inc. | |||
| 4473 Willow Rd., Suite 100 | ||||
| Pleasanton, CA 94588 | ||||
| Tel: 415 609 9875 | ||||
| Fax: 925 401 0676 | ||||
| FDA Registration No.: 3005791775 | ||||
| Contact | Kevin MacDonald | |||
| Vice President, Regulatory, Quality, Clinical Affairs | ||||
| Intended Use | The Modified NeoTract Anchor System is intended for the approximation of tissue in open | |||
| surgical procedures. | ||||
| Predicate Devices | ||||
| NeoTract Anchor System | ||||
| Manufactured by NeoTract, Inc. | K073651 | |||
| Nonabsorbable Surgical Suture | ||||
| Manufactured by Genzyme Corporation | K021019 |
K073644 StomaphyX Delivery Device , Fasteners and Accessories Manufactured by EndoGastric Solutions, Inc.
Device Description
The Modified NeoTract Anchor System is used for the approximation of soft tissue in open surgical procedures. It consists of a single use delivery device that delivers the permanently implanted Suture Anchor. The delivery system is comprised of a polycarbonate handle and trigger assembly connected to a stainless steel shaft.
Materials
All materials used in the manufacture of the Modified NeoTract Anchor System are suitable for this use and are comparable to the predicate products.
Testina
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
1
Summary of Substantial Equivalence
NeoTract, Inc. believes the Modified NeoTract Anchor System is substantially equivalent to the predicate products. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NeoTract, Inc. % Mr. Kevin F. MacDonald VP, Regulatory, Quality, Clinical Affairs 4473 Willow Road, Suite 100 Pleasanton, California 94588
JUL 15 2010
Re: K101252
Trade/Device Name: Modified NeoTract Anchor System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, GDW Dated: April 30, 2010 Received: May 4, 2010
Dear Mr. MacDonald:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
3
Page 2 - Mr. Kevin F. MacDonald
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
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3. Indications for Use Statement
| 510(k) Number (if
known): | This application
K101252 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Device Name: | Modified NeoTract Anchor System |
| Indications for Use: | The Modified NeoTract Anchor System is intended for the
approximation of tissue in open surgical procedures. |
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (Per 21 CFR 801 Subpart C)
JUL 15 2010
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kisone for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101252