(173 days)
Not Found
Not Found
No
The summary describes a surgical suture and contains no mention of AI, ML, image processing, or data analysis typically associated with AI/ML medical devices.
No
The device, SERRALGUT™ sutures, is used for soft tissue approximation and ophthalmic procedures, which are corrective or supportive actions rather than directly treating a disease or condition to restore health.
No
Explanation: The device, SERRALGUT™ sutures, is used for soft tissue approximation and ophthalmic procedures, indicating it is a therapeutic or surgical device rather than one designed for diagnosis.
No
The device description is not found, but the intended use clearly describes a physical medical device (sutures) used in surgical procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as sutures for general soft tissue approximation and ophthalmic procedures. This is a surgical device used in vivo (within the body) for physical repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used to perform tests outside the body on biological samples. This description clearly points to a device used inside the body during surgery.
N/A
Intended Use / Indications for Use
SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or opthalmic procedures, but not for use in cardiovascular and neurological procedures.
Product codes
GAL
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4830 Absorbable surgical gut suture.
(a)
Identification. An absorbable surgical gut suture, both plain and chromic, is an absorbable, sterile, flexible thread prepared from either the serosal connective tissue layer of beef (bovine) or the submucosal fibrous tissue of sheep (ovine) intestine, and is intended for use in soft tissue approximation.(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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features the department's name arranged in a circular fashion around a symbol. The symbol consists of three stylized human profiles facing to the right, with flowing lines above them, creating a sense of movement and connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2002
Serral, S.A. de C. V. H & *A Consultants c/o Scott Henderson 2584 Saddlewood Lane Palm Harbor, Florida 34685
Re: K020597
Trade/Device Name: SERRALGut™ Suture Regulation Number: 878.4830 Regulation Name: Suture, absorbable, natural, plain and chromic Regulatory Class: Class II Product Code: GAL Dated: July 5, 2002 Received: July 9, 2002
Dear Mr. Henderson:
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 (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.
1
Page 2 - Mr. Scott Henderson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Stept Rwdw
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
510(k) Number (if known): K020597
SERRALGUT™, Absorbable Surgical Sutures, Plain and Chromic Device Name:
Indications for Use:
SERRALGUT™ sutures are indicated for use in general soft tissue approximation and/or SERVALOOT - surares are thalmic procedures, but not for use in cardiovascular and neurological procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
| (Division Sign-Off) |
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K020597 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
SECTION III, PAGE 1