(165 days)
Not Found
No
The summary describes a standard surgical suture and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
No
Explanation: This device is a surgical suture used for approximation and ligation of tissues. While it assists in closing wounds, its primary function is mechanical support during healing, not directly treating a disease or condition for therapeutic benefit, which generally involves interventions to cure, mitigate, treat, or prevent disease.
No
The device is a surgical suture used for tissue approximation and ligation, not for diagnosing conditions or diseases. Its function is to hold tissues together, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a surgical suture, which is a physical, hardware medical device. There is no mention of software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "general soft tissue approximation and/or litigation including use in cardiovascular, ophthalmic, and neurological procedures." This describes a surgical device used in vivo (within the body) for physical repair and joining of tissues.
- Device Description: The description details a "sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene." This is a physical material used for surgical procedures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does none of that.
The information provided describes a standard surgical suture, which is a Class II medical device used for surgical procedures, not an IVD.
N/A
Intended Use / Indications for Use
The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue approximation and/or litigation including use in cardiovascular, ophthalmic, and neurological procedures.
Product codes
GAW
Device Description
The DemeTECH polypropylene sutures are inert, non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polylefin. The suture is pigmented to enhance visibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pronova Non-Absorbable Suture - Ethicon K001625
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY 16 2005
K043330
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | DemeTECH
3530 NW 115th Ave.
Miami, FL 33178
U.S.A |
|-------------------------|------------------------------------------------------------|
| | Phone: 305-597-5277
Fax: 305-437-7607 |
| Contact Person: | Luis Arguello |
| Date of Summary: | November 1, 2004 |
| Trade/Proprietary Name: | DemeTECH Polypropylene Surgical Sutures |
| Classification Name: | Suture, nonabsorbable, synthetic, polypropylene |
| Product Code: | GAW |
| Predicate Device: | Pronova Non-Absorbable Suture - Ethicon K001625 |
Intended Use:
The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue approximation and/or litigation including use in cardiovascular, ophthalmic, and neurological procedures.
Device Description:
The DemeTECH polypropylene sutures are inert, non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polylefin. The suture is pigmented to enhance visibility.
1
| K043330 Pg. 2 of 2 | |||
|---|---|---|---|
| Size Range | 10-0 to 8-0 and 6-0 to 2 | 10-0 to 8-0 and 6-0 to 2 | |
| Thread Diameter | |||
| U.S.P sizes | 10-0 to 8-0 and 6-0 to 2 | 10-0 to 8-0 and 6-0 to 2 | |
| Metric sizes in mm | 0.2 to 0.4 and 0.7 to 5.0 | 0 - .350 to .399mm | |
| Packaging | Cartons of 12, 24 and 36 | Cartons of 12, 24 and 36 | |
| Thread Length | 45 -100 cm | Variety of Lengths | |
| Thread Color | Pigmented Blue | Pigmented and Clear | |
| Sterilization | Ethylene Oxide | Ethylene Oxide | |
| Application | Single Use Only | Single Use Only |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned inside a circle, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged around the upper half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 6 2005
Demetech Corporation C/o Mr. Arthur J. Ward AJW Technology Consultants Incorporated 962 Allegro Lane Apollo Beach, Florida 33572
Re: K043330
Trade/Device Name: DemeTech Polypropylene Surgical Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: April 27, 2005 Received: April 28, 2005
Dear Mr. Ward:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nevers forced your your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered prior to 1125 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette (110) the elevice, subject to the general controls provisions of the Act. The r ou rakyontrols 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 r louse be advisou alla i hat your device complies with other requirements of the Act that I Drivias Intatutes and regulations administered by other Federal agencies. You must or any 1 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 – Mr. Arthur J. Ward
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and no your finding of substantial equivalence of your device to a legally promation in the 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 In you 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 other general 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/industry/support/index.html.
Sincerely yours,
Signature
Miriam C. Provost, Ph.D. Acting 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
510(k) Number (if known): K043330
Device Name: DemeTECH Polypropylene Surgical Suture
Indications for Use:
The DemeTECH Polypropylene Surgical Suture is indicated for use in general soft tissue The Demor LOTT For Proportion including use in cardiovascular, ophthalmic, and neurological procedures.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)