(88 days)
Not Found
No
The description focuses on a manual surgical instrument made of stainless steel and polymers, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is a surgical instrument used to grasp a suture needle during endoscopic/laparoscopic procedures, not to provide therapy itself.
No
The device is described as a surgical instrument used for grasping suture needles during endoscopic/laparoscopic procedures, not for diagnosing conditions.
No
The device description explicitly states it is a "single use, manual surgical instrument" constructed of "Surgical Stainless Steel with a handle constructed of medical grade polymers," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- UroMed Needle Grasper Function: The UroMed Needle Grasper is a surgical instrument used during a surgical procedure to manipulate a suture needle inside the patient's body. It is a tool for performing a surgical task, not for analyzing biological samples.
The description clearly states its use in endoscopic/laparoscopic surgical procedures for internal suturing. This is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The UroMed Needle Grasper is intended to be used during endoscopic/laparoscopic surgical procedures to hold a suture needle allowing for suture passing.
The UroMed Needle Grasper is indicated for use by the endoscopic/laparoscopic surgeon for internal suturing under direct vision. The device is designed to grasp a suture needle for manipulation by the surgeon. The device will be used in bladder neck suspension procedures for female urinary incontinence due to urethral hypermobility.
Product codes (comma separated list FDA assigned to the subject device)
KOG
Device Description
The UroMed Needle Grasper is a single use, manual surgical instrument for use during endoscopic/laparoscopic surgical procedures. The Needle Grasper will be used through an endoscopic/laparoscopic operating channel or under open surgical procedures. The instrument will be used to place and pass suture in bladder neck suspension procedures (urethropexy).
The device is constructed out of Surgical Stainless Steel with a handle constructed of medical grade polymers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
endoscopic/laparoscopic surgeon
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JAN 3 0 1998
510(k) Summary of Safety and Effectiveness UroMed® Needle Grasper
Company Name
UroMed Corporation 64 A Street Needham, MA 02194
Official Contact
Frederick Tobia Director, Clinical and Regulatory Affairs
Device Name
| Proprietary Name: | UroMed® Needle Grasper |
|---|---|
| Common Name: | Endoscope/Laparoscope and Accessories - Needle Driver |
| Classification Name(s): | 21 CFR § 876.1500 Endoscope and Accessories |
| 21 CFR § 876.4730 Manual Surgical Instruments |
Predicate Devices used for Substantial Equivalence
Cook Endoscopic Grasping Forceps Laurus Medical Suture Placement System
K924196 K933698
Intended Use
The UroMed Needle Grasper is intended to be used during endoscopic/laparoscopic surgical procedures to hold a suture needle allowing for suture passing.
Indications for Use
The UroMed Needle Grasper is indicated for use by the endoscopic/laparoscopic surgeon for internal suturing under direct vision. The device is designed to grasp a suture needle for manipulation by the surgeon. The device will be used in bladder neck suspension procedures for female urinary incontinence due to urethral hypermobility.
UroMed® Needle Holder - 510(k) 10/31/97
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1
Description
The UroMed Needle Grasper is a single use, manual surgical instrument for use during endoscopic/laparoscopic surgical procedures. The Needle Grasper will be used through an endoscopic/laparoscopic operating channel or under open surgical procedures. The instrument will be used to place and pass suture in bladder neck suspension procedures (urethropexy).
The device is constructed out of Surgical Stainless Steel with a handle constructed of medical grade polymers.
Summary of Standards Achieved
ASTM F899-84 Standards for Stainless Steel Billet, Bar and Wire for Surgical Instruments.
USP Class VI Biocompatibility.
Summary
In summary, the UroMed Needle Grasper is substantially equivalent to legally marketed devices. Quality System Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.
UroMed® Needle Holder - 510(k) 10/31/97
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2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with three flowing lines representing the body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
.
Mr. Frederick Tobia · Director, Clinical and Regulatory Affairs UroMed Corporation 64 A Street Needham, Massachusetts 02194
Re: K974137 UroMed® Needle Grasper Trade Name: Regulatory Class: II Product Code: KOG Dated: October 31, 1997 Received: November 3, 1997
Dear Mr. Tobia: . .
We have reviewed your Section 510(k) 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 895. A substantially equivalent_determination_assumes_compliance_with, the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Page 2 - Mr. Frederick Tobia
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
K974137
510(k) Premarket Notification UroMed® Needle Grasper
510(k) Number (if known): K97
Device Name: UroMed® Needle Grasper
Indication for Use: The UroMed Needle Grasper is indicated for use by the endoscopic/laparoscopic surgeon for internal suturing under direct vision. The device is designed to grasp a suture needle for manipulation by the surgeon. The device will be used in bladder neck suspension procedures for female urinary incontinence due to urethral hypermobility.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Acosta
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K974137
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UroMed® Needle Holder - 510(k) 10/31/97