(83 days)
the cxisting Opus SmartStitch® Suture Device
Not Found
No
The device description focuses on a manually powered suture punch and does not mention any computational or data-driven features indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
No
The device is strictly used for suturing soft tissues during surgical procedures. It does not provide any therapeutic effect to the patient.
No
The device description states its purpose is for the placement of suture through soft tissue, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "hand held, manually powered suture punch" which is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "placement of suture through soft tissue in endoscopic and other limited access procedures." This describes a surgical tool used on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a "hand held, manually powered suture punch for the delivery of a suture needle through soft tissue." This further reinforces its function as a surgical instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information.
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
Is indicated for use for in placement of suture through soft tissue in endoscopic and other limited access procedures.
Product codes
GAT
Device Description
The Opus Medical SpeedStitch™ Suture Device is intended for use in endoscopic procodures as well as other limited access open procedures for the purpose of suturing soft tissues. The wen us oner minned docess open preedStitch™ is based on a hand held, manually powered suture punch for the dclivery of a suture needle through soft tissue. The device delivers a simple stitch using USP #2 braided suture.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
the cxisting Opus SmartStitch® Suture Device.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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
Opus Medical, Inc.
510(k) Notification
K042031 p.1/2
SpeedStitch™ Suture Device
Page 9 of 53
Section 4: 510(k) Summary
| 510(k) Number: | |
|---|---|
| Manufacturer: | Opus Medical, 27127 Calle Arroyo, Suite 1924 San Juan Capistrano, CA. 92675 |
| Contact Person: | Laura Kasperowicz, Ph: (949) 234-0400, Fax: 234-0493 E-Mail: Lkasperowicz@opusmedical.com |
| Date Prepared: | July 26, 2004 |
Device Information:
| Trade Name: | Opus SpeedStitch™ Suture Device |
|---|---|
| Common Name: | Suture Punch; Endoscopic Accessories |
| Classification Name: | Endoscope and Accessories per |
Indications for Use:
Is indicated for use for in placement of suture through soft tissue in endoscopic and other limited access procedures.
Substantial Equivalence
The Opus SpeedStitch™ Suture Device is substantially equivalent in design and intended use to the cxisting Opus SmartStitch® Suture Device.
21 CFR 876.1500
Device Description:
The Opus Medical SpeedStitch™ Suture Device is intended for use in endoscopic procodures as well as other limited access open procedures for the purpose of suturing soft tissues. The wen us oner minned docess open preedStitch™ is based on a hand held, manually powered suture punch for the dclivery of a suture needle through soft tissue. The device delivers a simple stitch using USP #2 braided suture.
Image /page/0/Picture/12 description: The image shows a close-up of text that appears to be from a document or label. The text includes "FDA/CEN/085/PMO" vertically aligned on the right side. To the left of this, "2004 JUL 28 P 1:32" is also vertically aligned, suggesting a date and time stamp. The text is clear, but the overall image quality is somewhat grainy.
1
Opus Medical, Inc.
510(k) Notification
:
:
SpeedStitch™ Suture Devic Page 10 of 53
:
SECTION 5: CLASS III CERTIFICATION AND SUMMARY
Not applicable. This device is Class II.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2004
Ms. Laura N. Kasperowicz Regulatory Affairs Opus Medical, Inc. 27127 Calle Arroyo, Suite 1924 San Juan Capistrano, California 92675
Re: K042031
Trade/Device Name: Opus SpeedStitch™ Suture Device Regulation Number: 21 CFR 878.5000 Regulation Name: Synthetic Non-absorbable PET suture Regulatory Class: II Product Code: GAT Dated: September 28, 2004 Received: September 30, 2004
Dear :
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your section 910(t) premier is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosuly to regary manators of the Medical Device Amendments, or to commerce prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug. devices that have been recuired in accerdance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicat and Cosmetic Act (Act) that do not require approvide on the general controls provisions of the Act. The You may, merciole, market the de result of the Act include requirements for annual registration, listing of general controls provisions of the riot 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 II your device is classifica (sociation major regulations affecting your device can
may be subject to such additional controls. Existing major and controllive ED treat may be subject to such additional controller Lines and to 898. In addition, FDA may oc found in the Oods neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3188aarse or our device complies with other requirements of the Act that I DA has made a acterimations administered by other Federal agencies. You must of any recetal statutes and regarants ancluding, but not limited to: registration and listing (21 Comply with an the Not 8 requirements)01); good manufacturing practice requirements as set CFR Part 807); adoling (21 OFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to oegill marketing your article equivalence of your device to a legally premarket notification. The PDA midnig of substance of the more of 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
r the later the may on any 10, 2011 5, 11 hours have mote the regulation en if you desire specific advice for your aconce on on one note the regulation entitled, contact the Office of Complance at (210) = 16 % = 0 % = 0 % = 0 % = 0 % = 0 % = 0 % = 0 % = 0 % = 0 % = 0 % = 0 % = 0 " Misbranding by reference to premance notifications.
other general information on your responsibilities under the Act from the 1990 628.00 other general information on your responsionnes and its toll-free number (800) 638-2041 or Manufacturers, International and Oomes http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
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
K 04 203/
Opus Medical, Inc.
510(k) Notification
SpeedStitch™ Suture Device Page 8 of 53
SECTION 3: STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Opus SpecdStitch™ Suture Device
Indications for Use:
Is indicated for use for in placement of suture through soft tissue in endoscopic and other limited access procedures.
Prescription Use X (Per CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_ K642031________________________________________________________________________________________________________________________________________________________