(88 days)
K930826, N11397
Not Found
No
The document describes a simple, non-absorbable silk suture with a pre-attached needle, and the performance studies focus on standard physical and biocompatibility tests, with no mention of AI/ML or related concepts.
No
The device is a non-absorbable silk suture used for general soft tissue approximation, which is a tool used in a therapeutic procedure (suturing) but is not itself a therapeutic device that delivers therapy or treatment.
No
The device is a non-absorbable silk suture intended for soft tissue approximation. Its purpose is to physically approximate tissues during surgery, not to diagnose medical conditions.
No
The device description clearly outlines a physical medical device (suture and needle) and the performance studies focus on physical properties and biocompatibility, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a non-absorbable silk suture intended for use in general soft tissue approximation. This is a surgical device used directly on the patient's body during a procedure, not for testing samples outside the body.
The information provided focuses on the physical characteristics of the suture and needle, its mechanical properties (tensile strength, needle attachment, diameter), and biocompatibility, all of which are relevant to a surgical implant/device, not an IVD.
N/A
Intended Use / 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.
Product codes
GAP
Device Description
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
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
The following tests were performed to demonstrate substantial equivalence: Suture Tensile Strength (USP 29:2006) Needle Attachment (USP 29:2006) Suture Diameter (USP 29:2006) Biocompatibility (ISO 10993-1:2003)
Key Metrics
Not Found
Predicate Device(s)
K930826, N11397
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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JUL 1 7 2007
510 (k) Summary
| Submitter: | ARROW International, Inc.
2400 Bernville Road
Reading, PA 19605-9607 USA |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Karl Nittinger
Regulatory Affairs Specialist
Phone: 610-378-0131, ext. 3405
Fax: 610-478-3128
Email: 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 to
which the device is
substantially 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 the
following 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 in
general soft tissue approximation, excluding use in
cardiovascular, ophthalmic and neurological tissues. |
| Technological
characteristics: | The proposed non-absorbable silk suture has the same
technological design characteristics as the predicate
devices. |
,一
1
|:2006) Needle Attachment (USP 29:2006) Suture Diameter (USP 29:2006) 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.
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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