(37 days)
Not Found
No
The summary describes a mechanical device for tissue approximation and does not mention any AI/ML components or functionalities.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used for "approximation of soft tissue," which is a surgical procedure, but the device itself isn't treating a disease in a therapeutic sense.
No
The device is described as an "Anchor System" intended for "approximation of soft tissue in open surgical procedures," which points to a surgical/therapeutic function, not diagnosis. There is no mention of diagnostic capabilities, image processing, or AI/ML.
No
The device description explicitly states it consists of a "single use delivery device" and "permanently implantable NeoTract Anchors" made of physical materials like nitinol and stainless steel. This indicates a hardware-based medical device, not a software-only one.
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 soft tissue in open surgical procedures." This describes a surgical tool used directly on a patient's body during a procedure.
- Device Description: The device consists of anchors and a delivery system, designed for physical implantation and tissue manipulation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The NeoTract Anchor System is intended for the approximation of soft tissue in open surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT, GDW
Device Description
The NeoTract Anchor System consists of a single use delivery device that delivers up to two permanently implantable NeoTract Anchors. A NeoTract Anchor consists of one nitinol tube connected by nonabsorbable monofilament suture to a stainless steel pin with locking ring.
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
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatibility testing results demonstrate that the device is in compliance with ISO 10993-1:2003 - Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing.
Bench testing results demonstrate that the device is in compliance with USP 30:2007; Class II Special Controls Guidance Document Surgical Sutures; Guidance for Industry and FDA; the medical community expectations and the product labeling. Bench testing results also demonstrate that the device performance is substantially equivalent to the predicate device, the NeoTract Anchor (K061700).
Animal testing results further demonstrate that the device does not present any issues of safety or effectiveness in relation to its predicate, the NeoTract Anchor (K061700).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Section 5: 510(k) Summary
K073651
Page 1 of 2
Device Information
| Category | Comments |
|---|---|
| Sponsor: | NeoTract, Inc. |
| 4473 Willow Rd., Suite 100 | |
| Pleasanton, CA 94588 | |
| Tel: 925 401 0700 | |
| Fax: 925 401 0699 | |
| Correspondent Contact | |
| Information: | Suzan Moser |
| NeoTract, Inc. | |
| 4473 Willow Rd., Suite 100 | |
| Pleasanton, CA 94588 | |
| Tel: 925 401 0627 | |
| Fax: 925 401 0667 | |
| Device Common Name: | Surgical Suture |
| Device Classification & Codes: | Class II, GAT, GDW |
| Device Classification Name: | Nonabsorbable Poly(ethylene Terephthalate) Surgical |
| Suture | |
| Device Proprietary Name: | NeoTract Anchor System |
Predicate Device Information
| Predicate Devices: | NeoTract Anchor |
|---|---|
| Predicate Device Manufacturer: | NeoTract, Inc. |
| Predicate Device Common Name: | Surgical Suture |
| Predicate Device Classification: | Nonabsorbable Polypropylene Surgical |
| Suture | |
| Predicate Device Classification & Codes: | Class II, GAW, GDW |
Date Summary Prepared
December 21, 2007
Description of Device
The NeoTract Anchor System consists of a single use delivery device that delivers up to two permanently implantable NeoTract Anchors. A NeoTract Anchor consists of one nitinol tube connected by nonabsorbable monofilament suture to a stainless steel pin with locking ring.
Intended Use
The NeoTract Anchor System is intended for the approximation of soft tissue in open surgical procedures.
1
Comparison to Predicate Device
The NeoTract Anchor System is substantially equivalent to the predicate device. NeoTract Anchor, K061700, in Indications for Use, Class, Principal Operator, Use Location, Operating Principle, Design, How Shipped, Reuse, and Sterilization Method.
The testing described below demonstrates that differences in the devices do not raise any issues of safety or effectiveness.
NeoTract concludes that the devices are substantially equivalent.
Summary of Supporting Data
Biocompatibility testing results demonstrate that the device is in compliance with ISO 10993-1:2003 - Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing.
Bench testing results demonstrate that the device is in compliance with USP 30:2007; Class II Special Controls Guidance Document Surgical Sutures; Guidance for Industry and FDA; the medical community expectations and the product labeling. Bench testing results also demonstrate that the device performance is substantially equivalent to the predicate device, the NeoTract Anchor (K061700).
Animal testing results further demonstrate that the device does not present any issues of safety or effectiveness in relation to its predicate, the NeoTract Anchor (K061700).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem featuring a symbol that resembles a person embracing or supporting another, represented by abstract, flowing lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 1 2008
Neotract, Incorporated % Ms. Suzan Moser Vice President, Clinical and Regulatory Affairs 4473 Willow Road, Suite 100 Pleasanton, California 94588
Re: K073651
Trade/Device Name: NEOTRACT Anchor System Regulation Number: 21 CFR 878.5000, 21 CFR 878.4750 Regulation Name: Nonabsorbable polyamide surgical suture, Implantable staple. Regulatory Class: Class II Product Code: GAT, GDW Dated: December 21, 2007 Received: December 26, 2007
Dear Ms. Moser:
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. Iisting 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.
3
Page 2 – Ms. Suzan Moser
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Millman
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use Statement
K 073651 510(k) Number: This application
Device Name: NEOTRACT Anchor System
Indications For Use: The NeoTract Anchor System is intended for the approximation of soft tissue in open surgical procedures.
Prescription Use X (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)
Rdelm
Page 1 of
(Division Sign-Off,
Division of General, Restorative,
and Neurological Devices