(90 days)
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No
The summary describes a manual surgical instrument for placing sutures and contains no mention of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No.
The device is a surgical instrument for placing sutures, and its intended use is for wound closure procedures. It is used during a medical procedure, not for therapy or treatment of a disease or condition.
No
Explanation: The device is described as a surgical instrument for placing sutures, used for wound closure and repair, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it is a "single-use, surgical instrument for placing stainless steel sutures," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states the device is a "single-use, surgical instrument for placing stainless steel sutures" and its intended use is for "surgical wound closure procedures." This involves direct surgical intervention on the patient's body, not testing samples outside the body.
The information provided aligns with a surgical instrument used during a procedure, not a device used to analyze samples before or after a procedure for diagnostic purposes.
N/A
Intended Use / Indications for Use
The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).
Product codes (comma separated list FDA assigned to the subject device)
GAO, HCF
Device Description
A single-use, surgical instrument for placing stainless steel sutures.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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
NOV 1 9 2002
Image /page/0/Picture/1 description: The image shows a sequence of characters that appear to be handwritten. The sequence is "K022777". The characters are written in a simple, slightly irregular style, giving them a casual appearance. The image is clear and easy to read.
510(k) Summary
8/16/02
| Onux Medical, Inc. Contact Person: | Ruthann DePietro |
|---|---|
| Trade or Proprietary Name: | To be determined (Manual Touché) |
| Common or Usual Name: | Endoluminal suturing system |
| Classification Name: | Suture, nonabsorbable, steel, monofilament and multifilament |
Devices to Which Equivalence is Claimed
The present device is substantially equivalent to the Powered Touché Suturing System and the Salute Fixation System.
Description of Subject Device
A single-use, surgical instrument for placing stainless steel sutures.
Intended Use of Subject Device
The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).
| Powered Touché | Manual Touché | Salute | |
|---|---|---|---|
| Wire drive | Battery operated/dc motor | Manual | Manual |
| Wire type | 316 L Stainless steel | 316 L Stainless steel | 316 L Stainless steel |
| Wire diameter | 4-0 USP | ||
| .006 in. wire | 4-0 USP | ||
| .006 in. wire | .017 or .018 in. wire | ||
| Device usage | Reusable/Disposable | Disposable | Reusable/Disposable |
| Jaw manipulation | Manual | Manual | N/A |
| Jaw rotation | Battery operated/dc motor | Manual | Battery operated/dc motor |
Comparison of Technical Aspects
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Ms. Ruthann DePietro Vice President, Quality and Regulatory Affairs Onux Medical. Inc. 5 Merrill Drive Hampton, NH 03842
Re: K022777
Trade/Device Name: The Manual Touché Suturing System Regulation Number: 878.4495 and 878.4800 Regulation Name: Stainless steel suture, Manual surgical instrument for general use Regulatory Class: II Product Code: GAO, HCF Dated: August 16, 2002 Received: August 21, 2002
Dear Ms. DePietro:
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 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.
2
Page 2 -- Ms. Ruthann DePietro
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Miriam L'Provost
(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Indications for Use
INDICATIONS
The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).
Muriani C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number________________________________________________________________________________________________________________________________________________________________