(88 days)
The non-absorbable silk suture is intended for use in general soft tissue approximation, excluding use in cardiovascular, ophthalmic and neurological tissues.
The Arrow Non-Absorbable Silk Suture has the following characteristics: Black, braided silk suture thread of '000' (Metric 2) diameter, 30" (75 cm) suture thread length, Pre-attached, straight, stainless steel needle, 2-3/8" (60 mm) needle length
The provided document is a 510(k) summary for a Non-Absorbable Silk Suture. This type of device approval primarily relies on demonstrating substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies for a novel AI or diagnostic device. As such, many of the requested categories are not applicable or cannot be extracted from this specific document.
Here's an attempt to address the questions based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific numerical thresholds for performance metrics. Instead, "performance tests" were conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the new device's performance is comparable to or "favorable" compared to the predicate devices in these tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Suture Tensile Strength | Passed USP 29<881>:2006 compliance; safe, effective, and performs favorably compared to predicates. |
| Needle Attachment | Passed USP 29<871>:2006 compliance; safe, effective, and performs favorably compared to predicates. |
| Suture Diameter | Passed USP 29<861>:2006 compliance; safe, effective, and performs favorably compared to predicates. |
| Biocompatibility | Passed ISO 10993-1:2003 compliance; safe, effective, and performs favorably compared to predicates. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the tensile strength, needle attachment, suture diameter, or biocompatibility tests. It also does not mention what would typically be considered "test sets" in the context of AI or diagnostic device studies, nor does it refer to "data provenance" (country of origin, retrospective/prospective data). These are bench tests performed on the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to a submission for a physical medical device like a suture, which relies on standardized bench testing and biocompatibility assessments, not expert-derived ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Bench tests do not involve expert adjudication in the same way as clinical or AI performance studies.
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 is a physical medical device, not an AI or diagnostic tool designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance tests, the "ground truth" is defined by the standards themselves (e.g., USP 29 and ISO 10993-1). The device's characteristics are measured against the specifications outlined in these standards and against the performance of predicate devices. For biocompatibility, it's about whether the material elicits an adverse biological response according to the ISO standard.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
{0}------------------------------------------------
|< < > | \ | | |
1/2
JUL 1 7 2007
510 (k) Summary
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
|---|---|
| Contact person: | Karl NittingerRegulatory Affairs SpecialistPhone: 610-378-0131, ext. 3405Fax: 610-478-3128Email: karl.nittinger@arrowintl.com |
| Date summary prepared: | April 11, 2007 |
| Device trade name: | Non-Absorbable Silk Suture(21 CFR 878.5030, Product Code GAP) |
| Device common name: | Suture |
| Device classification name: | Natural non-absorbable silk surgical suture. |
| Legally marketed devices towhich the device issubstantially equivalent: | Surgical Specialties, Inc. Non-Absorbable Silk Suture(K930826) and Ethicon, Inc., Perma-Hand™ Non-Absorbable Silk Suture (N11397) |
| Description of the device: | The Arrow Non-Absorbable Silk Suture has thefollowing characteristics:Black, braided silk suture thread of '000' (Metric 2) diameter30" (75 cm) suture thread lengthPre-attached, straight, stainless steel needle2-3/8" (60 mm) needle length |
| Indications for use: | The non-absorbable silk suture is intended for use ingeneral soft tissue approximation, excluding use incardiovascular, ophthalmic and neurological tissues. |
| Technologicalcharacteristics: | The proposed non-absorbable silk suture has the sametechnological design characteristics as the predicatedevices. |
,一
{1}------------------------------------------------
|< © 2 || || ||
| Performance tests: | The following tests were performed to demonstrate substantial equivalence:Suture Tensile Strength (USP 29<881>:2006) Needle Attachment (USP 29<871>:2006) Suture Diameter (USP 29<861>:2006) Biocompatibility (ISO 10993-1:2003) |
|---|---|
| Assessment of non-clinical performance data: | The results of the bench tests demonstrate that Arrow's non-absorbable silk suture is safe, effective and performs favorably when compared to the Surgical Specialties, Inc. and Ethicon, Inc. predicate sutures. |
| Summary | Arrow International's Non-Absorbable Silk Suture has the same intended use as the Ethicon, Inc. predicate device. Based on the assessment of non-clinical performance data to verify this new intended use, and the technological characteristic comparison, Arrow's non-absorbable silk suture is substantially equivalent to the legally marketed predicate devices. |
:
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2007
Arrow International Inc. % Mr. Karl J. Nittinger Regulatory Affairs Specialist P.O. Box 12888 Reading, Pennsylvania 19612
Re: K071111
Trade/Device Name: Non-Absorbable Silk Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural nonabsorbable silk surgical suture Regulatory Class: II Product Code: GAP Dated: April 11, 2007 Received: April 20, 2007
Dear Mr. Nittinger:
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 mav 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.
{3}------------------------------------------------
Page 2 - Mr. Karl J. Nittinger
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 (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
071111 1/1
Indications for Use Statement
510(k) Number (if known):
Device Name: Non-Absorbable Silk Suture
Indications for Use: The non-absorbable silk suture is intended for use in general soft tissue approximation, excluding use in cardiovascular, ophthalmic and neurological tissues.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurance of CDRH, Office of Device Evaluation (ODE) Division Sign-O (Division Sign-Only Division of Goal Devices
and Neurological Devices 510(k) Num
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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.