(20 days)
Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopaedic surgeries.
The Force Fiber Blue Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 2-0 through 2 meeting USP requirements except for oversized diameter.
This document is a 510(k) premarket notification for a surgical suture. It demonstrates substantial equivalence to a predicate device rather than providing a study proving the device meets specific acceptance criteria in the way a diagnostic AI device would.
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 an analysis based on the provided document:
Acceptance Criteria and Study Details (Not Applicable for this Submission Type)
Since this is a 510(k) submission for a surgical suture establishing substantial equivalence, the concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as typically applied to diagnostic AI algorithms (e.g., sensitivity, specificity thresholds) does not directly apply. Instead, the submission focuses on demonstrating that the new device (Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture) is as safe and effective as a legally marketed predicate device (Force Fiber Polyethylene Non-Absorbable Surgical Suture).
The evaluation is based on technological characteristics and their equivalence to the predicate, along with meeting general regulatory requirements (USP for suture sizes, general controls).
The document states: "The technological characteristics are the same as or equivalent to the predicate device. The dimensional specification change does not adversely affect safety and effectiveness." This is the core "proof" of equivalence for this type of device, rather than a clinical performance study with statistical metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Not directly applicable in the context of diagnostic AI acceptance criteria. The "acceptance" for this device is based on demonstrating substantial equivalence to a predicate by meeting (or being equivalent to) its technological characteristics and regulatory standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Composition (Equivalent to predicate) | Composed of ultra high molecular weight polyethylene (UHMWPE), same as predicate. |
| Sterility | Sterile (as required for surgical sutures). |
| Non-absorbability | Non-absorbable (same as predicate). |
| Intended Use (Equivalent to predicate) | To approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries (same as predicate). |
| Meeting USP Requirements (Except for size for oversized) | Available in sizes 2-0 through 2, meeting USP requirements except for oversized diameter. The dimensional change is stated not to adversely affect safety and effectiveness. This implies that other critical physical/mechanical properties are still within acceptable (USP-like) ranges. |
| Technological Characteristics (Equivalent to predicate) | Stated to be "the same as or equivalent to the predicate device." |
| Safety and Effectiveness (Not adversely affected by changes) | "The dimensional specification change does not adversely affect safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission does not involve a "test set" in the sense of a dataset for an algorithm. It's a review of device design and specifications against a predicate.
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)
Not applicable. No expert ground truth establishment for a test set was performed or documented in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set was performed or documented.
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
Not applicable. This device is a surgical suture, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a surgical suture, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this type of device, "ground truth" relates to material properties, manufacturing specifications, and biological compatibility, which are assessed through standard engineering and biocompatibility testing, not through expert consensus on diagnostic images or pathology. The document doesn't detail specific testing.
8. The sample size for the training set
Not applicable. No training set for an algorithm is involved.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm is involved.
In summary: The provided document is a 510(k) summary for a medical device (surgical suture). It focuses on demonstrating substantial equivalence to a predicate device based on material, design, and intended use, rather than presenting a performance study against specific acceptance criteria for a diagnostic algorithm.
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MAR 1 5 2004
SUMMARY OF SAFETY AND EFFECTIVENESS
Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Teleflex Medical submits this summary of safety and effectiveness.
Submitter Name, Address, and Date of Submission 1.
Angela Tran Regulatory Affairs Supervisor Teleflex Medical 2917 Weck Drive Research Triangle Park, NC 27709 (919) 361-4008 Telephone: (919) 361-3966 Facsimile: Submitted: February 23, 2004
Name of the Device, Common, Proprietary (if known), and Classification 2.
| Classification Narne: | Suture |
|---|---|
| Common Name: | Suture |
| Proprietary Name: | Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture |
| Classification: | Class II, 21CFR §878.5000 |
3. Identification of the legally marketed device to which the submitter claims equivalence
The Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture described in this submission is substantially equivalent to previously cleared suture, Force Fiber Polyethylene Non-Absorbable Surgical Suture.
4. Description of the Device
The Force Fiber Blue Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 2-0 through 2 meeting USP requirements except for oversized diameter.
5. Intended Use of the Device
The Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.
6. Summary of Technological Characteristics
The technological characteristics are the same as or equivalent to the predicate device. The dimensional specification change does not adversely affect safety and effectiveness.
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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare organizations.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2004
Ms. Angela Tran Regulatory Affairs Supervisor Teleflex Medical 2917 Weck Drive Research Triangle Park, North Carolina 27709
Re: K040472 Trade/Device Name: Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Surgical Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: February 16, 2004 Received: February 24, 2004
Dear Ms. Tran:
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.
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Page 2 - Ms. Angela Tran
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The IDA 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 (301) 594-4659. 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 yours,
Miriam C. 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
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Indications for Use
510(k) Number (if known): K040472
Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Device Name: Surgical Suture
Force Fiber Blue Co-Braid Polyethylene Non-Absorbable Indications For Use: Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including the use of allograft tissue for orthopaedic surgeries.
| 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
| tage | lot | |
|---|---|---|
| ---------- | --------- | -- |
510(k) Number_K040472
§ 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.