(28 days)
Trelon® sutures are intended for use in general and soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological procedures.
The Trelon® sutures are a polyamide (Nylon) multifilament suture that is available in common sizes and lengths and is available with or without pre-attached needles.
The provided text describes Trelon® Polyamide Sutures and their substantial equivalence to a predicate device, Dafilon® sutures. However, it does not contain detailed information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test/training sets, expert qualifications, or ground truth establishment.
Here's a breakdown of what is available and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| USP Requirements | The Trelon® sutures meet all USP requirements. |
Missing Information: The document does not specify which USP requirements were assessed (e.g., tensile strength, knot security, degradation profile, sterility, etc.) nor does it provide the quantitative performance data against those requirements. It only states that the device "meets all USP requirements."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not mention a specific "test set" or provide details on the sample size used for performance evaluation, nor does it specify data provenance (country, retrospective/prospective). The assessment appears to be based on compliance with USP standards, which are general specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: Not applicable as there's no mention of a ground truth established by experts for a specific test set. The performance assessment relies on meeting general USP standards, not on expert evaluation against a particular dataset.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: Not applicable. There is no mention of a test set or an adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Missing Information: Not applicable. This device is a surgical suture, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: Not applicable. This device is a surgical suture, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing Information: The "ground truth" equivalent here is the set of USP requirements for polyamide sutures. The device's performance is gauged against these established industry standards, not against clinical outcomes, pathology, or expert consensus on a particular dataset.
8. The sample size for the training set
Missing Information: Not applicable. This refers to a medical device (suture), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Missing Information: Not applicable. Similar to point 8, this refers to a medical device, not an algorithm.
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MAR 2 8 2006
Trelon® Polyamide Sutures
Page 1 of 2
510(k) SUMMARY (as required by 21 CFR 807.92) B.
Craniofacial Plate & Screw System 24 February 2006
- Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 2916714
- CONTACT: Matthew M. Hull 800-258-1946 (phone) 610-791-6882 (fax) matt.hull@aesculap.com (email)
Trelon® Polyamide Multifilament Nonabsorbable Suture TRADE NAME:
COMMON NAME: Polyamide Nonabsorbable Suture
CLASSIFICATION NAME: Suture, Nonabsorbable, Synthetic, Polyamide
REGULATION NUMBER: 878.5020
PRODUCT CODE: GAR
SUBSTANTIAL EQUIVALENCE
Aesculap®, Inc. believes that the Trelon® sutures described here are substantially equivalent to the Dafilon® sutures previously cleared in the Aesculap Premarket Notification #K990090.
DEVICE DESCRIPTION
The Trelon® sutures are a polyamide (Nylon) multifilament suture that is available in common sizes and lengths and is available with or without pre-attached needles.
INDICATIONS FOR USE
Trelon® sutures are intended for use in general and soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))
The Trelon® sutures use the exact same material polyamide (Nylon 6.6) as the predicate Dafilon® device with only difference being that the new device is a multifilament suture as opposed to monofilament. As with other multifilament sutures the Trelon® also uses as silicon coating.
PERFORMANCE DATA
The Trelon® sutures meet all USP requirements.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles suggesting community and connection. The figure is abstract and uses curved lines to create a sense of movement and unity.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2006
Aesculap® Inc. c/o Matthew M. Hull 3773 Corporate Parkwayental Projects Center Valley, PA 18034
Re: K060528
Trade/Device Name: Trelon Polyamide Sutures Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polymade surgical suture Regulatory Class: II Product Code: GAR Dated: February 24, 2006 Received: March 1, 2006
Dear Mr. Hull:
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 docs 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Matthew M. Hull
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 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 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 vours.
Herbert Lemon vo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
INDICATIONS FOR USE STATEMENT A.
KO60528 510(k) Number:
Device Name: Trelon Polyamide Sutures
Indications for Use:
Trelon® sutures are intended for use in general and soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological procedures.
Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Helmut Remer ng
Avision Sign-Off) Division of General, Restorative, and Neurological Devices
060528 510(k) Number
§ 878.5020 Nonabsorbable polyamide surgical suture.
(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; 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.