(20 days)
The Tegress™ Implant Needles are accessories for currently marketed endoscopes to allow delivery of injectable materials into tissues during an endoscopic procedure.
The Tegress™ Implant Needle is an accessory for currently marketed endoscopes and is used for tissue during an endoscopic procedure. The Tegress™ Implant Needle is a Transurethral Flexible Needle with Stabilizing Cannula that consists of a stainless steel non-coring needle at the tip. A full-length needle guard protects the species of a semi-rigid catheter/tubing and The Transurethral Needle and Stabilizing Cannula with Working Working Channel Seal. Working Channel Geal. - The "Transarenial and are compatible with DMSO.
The provided text is a 510(k) summary for the Tegress™ Implant Needle, a medical device. This document describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or details regarding performance evaluation.
The "Performance Data Summary" section explicitly states: "The Tegress™ Implant Needle referenced in this submission is held to the same design, The Tegress™ Informance specifications as those needles currently manufactured by manufacture, and performance specification and validation activities for the modifications to the Tegress™ Implant Needle were conducted." This indicates that the claim of safety and effectiveness relies on its similarity to existing, already-approved devices, rather than a new standalone performance study with detailed acceptance criteria.
Therefore, I cannot provide the requested information from this document. The sections of your request that cannot be answered from the provided text are:
- A table of acceptance criteria and the reported device performance: No acceptance criteria or specific performance metrics are reported.
- Sample size used for the test set and the data provenance: No test set is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is detailed.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; this device is an implant needle, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this device is an implant needle, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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APR 6 2005
510 (k) Summary of Safety and EFFECTIVENESS INFORMATION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
- A. Submitter's Information:
| Submitter's Name: | C. R. Bard, Inc., Urological Division |
|---|---|
| Address: | 8195 Industrial Blvd.Covington, Georgia 30014 |
| Contact Person: | Terri Morris |
| Contact Person's Phone: | (770) 784-6774 |
| Contact Person's Fax: | (770) 784-6419 |
| Date of Preparation: | March 10, 2005 |
- B. Device Name:
| Trade Name: | Tegress™ Implant Needle |
|---|---|
| Common / Usual Name: | Endoscopic Needle |
| Classification Name: | Endoscope Accessory |
- C. Predicate Device Name:
| Trade Name: | Genyx Flexible Injection Needle#K001146 |
|---|---|
| ------------- | --------------------------------------------- |
- D. Device Description:
The Tegress™ Implant Needle is an accessory for currently marketed endoscopes and is used The Tegress - Implant Noodle is an account for tissue during an endoscopic procedure.
The Tegress™ Implant Needle is a Transurethral Flexible Needle with Stabilizing Cannula that The Tegress ™ Implant Needle is a Transcritive catheter portion with longitundinal consists of a stainless steel non-coring needle at the tip. A full-length needle guard protects the stripe, and a stamess steel norFormig nedule at the species of a semi-rigid catheter/tubing and The Transurethral Needle and Stabilizing Cannula with Working Working Channel Seal. Working Channel Geal. - The "Transarenial and are compatible with DMSO.
-
E. Intended Use:
The Tegress™ Implant Needles are accessories for currently marketed endoscopes to allow The Tegress - Implant Nobanoota to tissues during an endoscopic procedure. -
F. Technological Characteristics Summary:
The subject Tegress™ Implant Needle has the same intended use, design and fundamental scientific technology as the predicate device. -
G. Performance Data Summary:
The Tegress™ Implant Needle referenced in this submission is held to the same design, The Tegress™ Informance specifications as those needles currently manufactured by manufacture, and performance specification and validation activities for the modifications to the Tegress™ Implant Needle were conducted.
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Image /page/1/Picture/2 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle image.
APR 6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Terri Morris Regulatory Affairs Specialist C. R. Bard, Inc. Bard Urological Division 8195 Industrial Blvd. COVINGTON GA 30014-2655
Re: K050688
Trade/Device Name: Tegress™ Implant Needle Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBK Dated: March 16, 2005 Received: March 17, 2005
Dear Ms. Morris:
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 (Premarket Approval), 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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) This letter witi anow you'ls ought mating of substantial equivalence of your device to a legally prematics notification - The Persons 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 If you desire specific at the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, picase note the regulation entired, formation on your responsibilities under the Act from the 001:37). Tou may ooually of the ational and Consumer Assistance at its toll-free number (800) DNSION of 301) 443-6597 or at its Internet address http://www.fda.gov/cdrb/dsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Bard Urological Division, C.R. Bard, Inc. Tegress™ Implant Needle Premarket Notification [510(k)]
KOSCLE 88
Indications for Use Statement 1.3
510(k) Number (if known): __
Device Name: ____Tegress™ Implant Needle
Indications for Use:
The Tegress™ Implant Needles are accessories for currently marketed endoscopes to allow The Tegress - Implant Neodios art accessed.
delivery of injectable materials into tissues during an endoscopic procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of cdrh, office of device evaluation (ode) Over-The-Counter Use __ OR Prescription Use (Per 21 CFR 801.109)
(Optional Format 1/2/96)
Ylaucic bugden
(Division Sign-Off) Division of Reproductive, Abdor and Radiological De 510(k) Number
§ 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.