(60 days)
Not Found
No
The summary describes a mechanical suture device and does not mention any AI or ML components or functionalities.
No
This device is used for suture placement, which is a surgical tool, not a therapeutic device. It doesn't treat, cure, mitigate, or prevent disease.
No
The device is described as a suture device used for placement of sutures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a "Suture Device with PerfectPasser™ Connector," indicating a physical hardware component for placing sutures.
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 for "placement of braided polyester or polyethylene suture through soft tissue in endoscopic and other limited access procedures." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The description focuses on the mechanical function of placing sutures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic purposes. This device is a surgical tool used for tissue repair.
N/A
Intended Use / Indications for Use
The Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester or polyethylene suture through soft tissue in endoscopic and other limited access procedures.
Product codes
KOG
Device Description
The Opus® SmartStitch™Suture Device with PerfectPasser™ Connector is designed to allow the surgeon the option to place a simple stitch or a mattress stitch.
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
surgeon, endoscopic and other limited access procedures
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
ArthroCare Corporation Opus SmartStitch Suture Device with S-Connector Special Premarket Notification July 28, 2006
510(K) SUMMARY
ARTHROCARE CORPORATION Opus SmartStitch Suture Device with S-Connector
| General Information | OCT - 2 2006 |
|---|---|
| Submitter Name/Address: | ArthroCare Corporation |
| 680 Vaqueros Avenue | |
| Sunnyvale, CA 94085-3523 | |
| Establishment Registration No.: | 2951580 |
| Contact Person: | Laura N. Kasperowicz |
| Sr. Manager, Regulatory Affairs | |
| Date Prepared: | July 28, 2006 |
| Device Description | |
| Trade Name: | Opus® SmartStitch™ Suture Device |
| with PerfectPasser™ Connector | |
| Generic/Common Name: | Endoscopic suture device |
| Classification Name: | Endoscope and accessories |
| (Class II per 21 CFR 876.1500) | |
| Product Code: | KOG |
| Predicate Device | Opus SmartStitch Suture Device |
| K030170 (Cleared 07/28/03) |
Product Description
The Opus® SmartStitch™Suture Device with PerfectPasser™ Connector is designed to allow the surgeon the option to place a simple stitch or a mattress stitch.
Indications For Use
The Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester or polyethylene suture through soft tissue in endoscopic and other limited access procedures.
1
510(K) SUMMARY
Substantial Equivalence
By definition, substantial equivalence means that a device has the same intended use and technical characteristics as the predicate device, or has the same intended use and different technological characteristics, but can be demonstrated to be as safe and effective as the predicate device. The Opus" SmartStitch™ Suture Device with PerfectPasser™ Connector is substantially equivalent to the existing Opus® SmartStitch™ Suture Device with M-Connector cleared by the Food & Drug Administration (K030170). The differences between the Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector and the predicate device does not raise any questions regarding the safety and effectiveness. Furthermore, the materials are well characterized and have been used in the predicate device with the same indications. The device, as designed, is as safe and effective as the predicate device.
Summary and Reason for 510(k) Notification
The purpose of this 510(k) is to notify the Food and Drug Administration of a modification to the previously cleared device. The modification incorporates the same principal of operation and fundamental technology as the previously cleared Opus SmartStitch Suture Device with M-Connector. The primary difference is a modification to the suture delivery system, which will allow the surgeon the option to place a simple stitch or a mattress stitch. The proposed PerfectPasser™ Connector design incorporates dimensional modifications that allow increased tissue margin during placement of the stitch. The S-Connector design includes the use of the following alternative materials: glass-filled polycarbonate and a glass-filled nylon. The predicate device, the M-Connector, was originally cleared for use with a braided polyester suture. The PerfectPasser™ Connector has been designed to use either braided polyester suture or braided polyethylene suture. The product labeling has been changed to incorporate the new product name and alternative suture material.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
0C1 - 2 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ArthroCare Corporation % Ms. Laura N. Kasperowicz. Sr. Manager. Regulatory Affairs 680 Vaqueros Avenue Sunnyvale. California 94085-3523
Re: K062244
Trade/Device Name: Opus" SmartStitch" Suture Device with PerfectPasser" Connector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: K()G Dated: August 30, 2006 Received: September 13, 2006
Dear Ms. Kasperowicz:
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 cnactment 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 anrual registration, listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class !! (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 - Ms. Laura N. Kasperowicz
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 at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson
Mark N. lelkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number: K 062244
Opus SmartStitch™ Suture Device with PerfectPasser™ Connector Device Name:
Indications for Use:
The Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is indicated for use for placement of braided polyester and polyethylene suture through soft tissue in endoscopic and other limited access procedures.
Prescription Use (Part 21 CFR 801 Subpart D) X AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
NO
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Nolm
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062244