(25 days)
Not Found
No
The summary does not mention any terms related to AI or ML, nor does it describe any functionality that would typically involve these technologies. The device appears to be a mechanical suture placement tool.
No
The device is described as a "Suture Device" for placing sutures, which is a surgical tool, not a device used for treating a disease or medical condition.
No
The descriptions of the intended use and device function indicate it is for placing sutures, which is a therapeutic or repair function, not a diagnostic one. It does not identify a disease or condition.
No
The device description explicitly states it is a "Suture Device with PerfectPasser™ Connector," indicating a physical, hardware-based medical device for placing sutures.
Based on the provided information, the Opus® SmartStitch™ Suture Device with PerfectPasser™ Connector is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is used for the "placement of braided polyester and polyethylene suture through soft tissue." This is a surgical procedure performed directly on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use is for "placement of braided polyester and polyethylene suture through soft tissue in endoscopic and other limited access procedures." This describes a surgical intervention, not a diagnostic test.
Therefore, the Opus® SmartStitch™ Suture Device is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
OCW, KOG
Device Description
The Opus® SmartStitch™Suture Device with PerfectPasser is designed to allow the surgeon the option to place a simple stitch or a mattress stitch through soft tissue in endoscopic and other limited access procedures.
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)
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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ArthroCare Corporation Ms. Laura N. Kasperowicz Sr. Manager. Regulatory Affairs 15285 Alton Parkway, #200 Irvine, CA 92618
JUL 2 7 2015
Re: K070671
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: OCW Dated (Date on orig SE ltr): March 9, 2007 Received (Date on orig SE Itr): March 12, 2007
Dear Ms. Kasperowicz,
This letter corrects our substantially equivalent letter of April 6, 2007.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
1
Page 2 -
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive. Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
ArthroCare Corporation Opus SmartStitch Suture Device Special Premarket Notification March 9, 2007
INDICATIONS FOR USE STATEMENT
510(k) Number: K 070671
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)
Division Sign-Off
(Division Sign-Off) Division of General, Restorative, and Neurological De 510(k) Number
3
ArthroCare Corporation Opus SmartStitch Suture Device Special Premarket Notification March 9, 2007
510(K) SUMMARY
ARTHROCARE CORPORATION
OPUS SMARTSTITCH SUTURE DEVICE WITH PERFECTPASSER
APR - 6 2007
General Information
| 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: | March 9, 2007 |
| Device Description | |
| Trade Name: | Opus® SmartStitch™ Suture Device |
| 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 | K062244 (Cleared 10/02/06) |
Product Description
The Opus® SmartStitch™Suture Device with PerfectPasser is designed to allow the surgeon the option to place a simple stitch or a mattress stitch through soft tissue in endoscopic and other limited access procedures.
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.
4
ArthroCare Corporation Opus SmartStitch Suture Device Special Premarket Notification March 9, 2007 K090671 2/2
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 PerfectPasser Connector cleared by the Food & Drug Administration (K062244). The difference between the Opus® SmartStitch™ Suture Device and the predicate device does not raise any questions regarding the safety and effectiveness. Furthermore, the materials are well characterized. 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 PerfectPasser Connector. The primary difference includes the addition of a material.