No
The summary describes a mechanical suture retention device with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as a suture retention device used to facilitate soft tissue repair, indicating a therapeutic purpose.
No
The device is described as a "suture retention device" used to facilitate surgical repair, not to identify or diagnose a condition.
No
The device description clearly states it is a physical device made of polyester suture, poly(L-lactide) bar, stainless steel needle, and a plastic handle, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "suture retention device to facilitate percutaneous or endoscopic soft tissue repair." This describes a surgical or procedural device used directly on the patient's body.
- Device Description: The description lists components like polyester suture, poly(L-lactide) bar, stainless steel needle, and a plastic handle. These are all components of a surgical or procedural device, not a device used to test samples in vitro (outside the body).
- Anatomical Site: The anatomical sites mentioned (shoulder, meniscus, gastrostomy) are locations within the human body where surgical procedures are performed.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The RBM is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair.
The indications for the RBM are for use as a suture retention device to facilitate percuraneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repar), rotator cuff repair, meniscal repair, and gastrostomy.
Product codes
KGS, GAS, GAT
Device Description
The RBM is a suture retention device manufactured from polyester suture, poly(L-lactide) bar, stainless steel needle and a plastic handle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, shoulder, meniscal, gastrostomy
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4930 Suture retention device.
(a)
Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
K020480 (P. lofa)
SECTION V
510(k) Summary
RBM
MAR 1 2 2002
Date Prepared: January 25, 2002
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
A. Submitter
Smith & Nephew, Inc. Endoscopy Division 160 Dascomb Road Andover, MA 01810 508.261.3658
B. Company Contact
William McCallum Regulatory Specialist
C. Device Name
| Trade Name: | RBM |
|---|---|
| Common Name: | Suture Retention Device |
| Suture, Nonabsorbable, Polyester | |
| Classification Name: | Suture Retention Device (KGS) |
| Suture, Nonabsorbable, Synthetic, Polyester (GAS) |
D. Predicate Device
MR-III previously cleared by K002261.
E. Description of Device
The RBM is a suture retention device manufactured from polyester suture, poly(L-lactide) bar, stainless steel needle and a plastic handle.
1
K02 0480 (P.2 of 2)
D. Intended Use
RBM is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair.
The indications for the MR-III are for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair, rotator cuff repair, meniscal repair and gastrostomy.
E. Comparison of Technological Characteristics
Both the MR-III and the RBM are intended to be used to fixate soft tissue by anchoring the tissue internally from a single access point and securing the suture by a knot.
William McCallum Regulatory Specialist
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 2 2002
Mr. William McCallum Regulatory Affairs Specialist Smith & Nephew. Inc. Endoscopy Division 130 Forbes Boulevard Mansfield, Massachusetts 02048
Re: K020480
Trade Name: RBM Regulation Number: 878.5000 Regulation Name: Synthetic non-absorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: February 11, 2002 Received: February 13, 2002
Dear Mr. McCallum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 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.
3
Page 2 -- Mr. William McCallum
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" (21CFR 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,
Mark A. Milam
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
4
Page 1 of 1
510(k) Number : K020480
Device Name : RBM
Indications for Use :
The RBM is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue repair.
The indications for the RBM are for use as a suture retention device to facilitate percuraneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repar), rotator cuff repair, meniscal repair, and gastrostomy.
(PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 2.1 CFR 801.109
OR
Over-the-Counter
(Optional Format 1-2-96)
for Murle N. Milliman
vision Sign-Off) Division of General, Restorative and Neurological Devices
020480 510(k) Number _