(89 days)
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No
The 510(k) summary describes sutures, a physical medical device, and contains no mention of AI, ML, image processing, or data analysis typically associated with AI/ML-powered devices.
No
Explanation: SERRALNYL™ sutures are used for approximation and ligation of soft tissues, which are surgical tools or materials to close wounds and secure tissues, not devices that provide therapy for a disease or condition.
No
Explanation: The device, SERRALNYL™ sutures, is used for tissue approximation and ligation, which are therapeutic rather than diagnostic actions.
No
The 510(k) summary describes sutures, which are physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of SERRALNYL™ sutures is for "general soft tissue approximation and/or ligation". This describes a surgical procedure performed on the body, not a test performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or analytical methods
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Sutures are surgical implants used to close wounds or hold tissues together.
Therefore, SERRALNYL™ sutures fall under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SERRALNYL™ sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
Product codes
GAR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 5 2002
Serral, S.A. de C.V. c/o Mr. Scott Henderson President H & A Consultants 2584 Saddlewood Lane Palm Harbor, Florida 34685
Re: K020146
Trade Name: Serralny1™ Non-absorbable Surgical Sutures Regulation Number: 878.5020 Regulation Name: Non-absorbable polyamide surgical suture Regulatory Class: II Product Code: GAR Dated: January 22, 2002 Received: January 28, 2002
Dear Mr. Henderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave review for rear form have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to may 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 20, 1970, the chartence 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, (Act, that do not require appears to the general controls provisions of the Act. The general uncrolor, mainer and the Act include requirements for annual registration, listing of devices, oon one hereins or actice, 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 If your device 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 or any I 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.
A
Image /page/0/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
1
Page 2 - Mr. Scott Henderson
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin mains of substantial equivalence of your device to a legally premarket notification. THC PDF intellig of basification 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 and If you desire specific acrise for your avitro diagnostic devices), please contact the Office of additionally 21 CFN Far 067.10 to mix 12.0 million ally, for questions on the promotion and advertising of Compliance at (301) 597 1859 Fride of Compliance at (301) 594-4639. Also, please note the your do roo, pread of the reference to premarket notification" (21CFR Part 807.97). regulation chittied, Thisordians on your responsibilities under the Act may be obtained from the Outcr general information on your terpational 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,
Muriam C. Provost
for 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
2
INDICATIONS FOR USE
(020146 510(k) Number (if known):
SERRALNYL™, Non-absorbable Surgical Sutures Device Name:
Indications for Use:
SERRALNYL™ sutures are indicated for use in general soft tissue approximation and/or SENNALNTL - Surures are indicated 10, about almic and neurological procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
concurrence of cdrh, office of device evaluation (oDE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020146
Prescription Use
OR
Over-The-Counter Use _
SECTION III, PAGE 1