(165 days)
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.
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.
This 510(k) summary (K043330) is for a medical device called "DemeTECH Polypropylene Surgical Sutures." It demonstrates substantial equivalence to a predicate device, the Pronova Non-Absorbable Suture (K001625), rather than providing a study proving a device meets specific performance criteria.
Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the relevant information from the provided text.
Here's a breakdown of the acceptance criteria and related information based only on the provided text, acknowledging that a full clinical study with the listed criteria is not present in this document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for a 510(k) submission like this are primarily about demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety or effectiveness.
| Acceptance Criteria Category (implied by 510(k)) | Predicate Device Performance (Pronova, K001625) (as described in the 510(k)) | DemeTECH Device Performance (K043330) (as described in the 510(k)) |
|---|---|---|
| Intended Use | General soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. | General soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. |
| Material Composition | Isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin). | Isotactic crystalline stereoisomer of polypropylene (a synthetic linear polyolefin). |
| Non-Absorbable | Yes | Yes |
| Sterility | Sterile | Sterile |
| Pigmentation | Pigmented and Clear (for predicate) | Pigmented Blue (for DemeTECH) |
| Size Range (USP) | 10-0 to 8-0 and 6-0 to 2 | 10-0 to 8-0 and 6-0 to 2 |
| Thread Diameter (USP 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 - .350 to .399mm (likely a typo, suggesting a range) | 0.2 to 0.4 and 0.7 to 5.0 |
| Packaging | Cartons of 12, 24 and 36 | Cartons of 12, 24 and 36 |
| Thread Length | Variety of Lengths | 45 -100 cm |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Application | Single Use Only | Single Use Only |
Study Proving Device Meets Acceptance Criteria:
The provided document is a 510(k) summary, which is a premarket notification to demonstrate substantial equivalence to a predicate device. It does not present a detailed study proving the device meets specific performance criteria in the way a clinical trial or a standalone diagnostic study would. Instead, the "study" is the comparison made to the predicate device to satisfy the FDA's requirements for substantial equivalence.
The regulatory review process itself, based on the information provided in the 510(k) submission, served as the "proof" that the device meets the acceptance criteria for a 510(k) clearance. The FDA's letter (K043330, May 16, 2005) confirms that the device was determined to be "substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This document does not describe a clinical "test set" with a specific sample size in the context of typical device performance studies (e.g., patient data). The "test" is a comparison to the predicate device's specifications and performance.
- Data Provenance: Not applicable. The data is primarily comparative information from existing device specifications and regulatory submissions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This document does not involve experts establishing ground truth for a test set of data. The "ground truth" for a 510(k) comparison is the known, cleared specifications and performance of the chosen predicate device.
4. Adjudication Method for the Test Set
- Not applicable. There is no "adjudication method" in the context of a 510(k) comparison as there would be for a multi-reader study. The FDA reviews the provided data against the predicate device's known characteristics and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is not an MRMC study. It is a 510(k) submission for a surgical suture.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical suture, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" in this context is the established specifications, performance, and regulatory clearance of the predicate device (Pronova Non-Absorbable Suture - Ethicon K001625). The applicant (DemeTECH) asserts that their device is substantially equivalent to this predicate.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This is not an AI/ML device.
{0}------------------------------------------------
MAY 16 2005
K043330
510(K) SUMMARY (as required by 807.92(c))
| Submitter of 510(k): | DemeTECH3530 NW 115th Ave.Miami, FL 33178U.S.A |
|---|---|
| Phone: 305-597-5277Fax: 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 DiameterU.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
{4}------------------------------------------------
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)
§ 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.