(46 days)
Not Found
No
The description focuses on the mechanical components and function of an electrosurgical snare, with no mention of AI or ML.
Yes
The device is described as electrosurgically removing GI tract polyps. Electrosurgery is a therapeutic procedure, and removing polyps is a form of treatment.
No
The device is described as an electrosurgical tool for removing polyps, not for identifying or diagnosing medical conditions. It performs a therapeutic function.
No
The device description explicitly lists physical components like a handle, cable, snare loop, and sheath, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "electrosurgically remove GI tract polyps through the channel of an endoscope." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical instrument (handle, cable, snare loop, sheath) used for a surgical action (removing polyps). This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely interventional/surgical.
N/A
Intended Use / Indications for Use
The intended use of the subject device is to electrosurgically remove GI tract polyps through the channel of an endoscope.
Product codes
78 FDI
Device Description
The device consists of a handle, cable, snare loop and cable. The loop is attached to the handle assembly by means of the cable. The sheath is also connected to the handle assembly and collapses the loop upon its retraction into the sheath.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract
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
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).
0
971275
510(k) Summary:
| 1.) Submitter: | Mill-Rose Laboratories, Inc.
7310 Corporate Blvd.
Mentor, OH 44060
(216)255-7995
MAY 23 1997 | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------|--|
| 2). Contact Person: | Alan C. Poje | |
| 3.) Summary Preparation Date: | April 4, 1997 | |
| 4.) Classification Name: | Snare, Flexible (Accessory to Endoscopic Electrosurgical Unit) | |
| 5.) Common Name: | Disposable Polypectomy Snare | |
| 6.) Proprietary Name: | Mill-Rose Disposable Polypectomy Snare | |
| 7.) Substantially Equivalent Device: | K912254 - Cox Medical Enterprises, Cox Disposable Polypectomy Snare | |
| | K792343 - Mill-Rose Laboratories, Flexible Diathermic Snare | |
| | K951600 - Mill-Rose Laboratories, Rotatable Polypectomy Snare | |
8.) Description of Subject Device:
The device consists of a handle, cable, snare loop and cable. The loop is attached to the handle assembly by means of the cable. The sheath is also connected to the handle assembly and collapses the loop upon its retraction into the sheath.
9.) Intended Use:
The intended use of the subject device is to electrosurgically remove GI tract polyps through the channel of an endoscope
10.) Technological Characteristics:
The subject device has the same technological characteristics as the predicates. It is composed of the same type of materials and is of a similar design.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The eagle is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 1997
Mr. Alan C. Poje Director of Regulatory Affairs ... ......... Mill-Rose Laboratories, Inc. 7310 Corporate Boulevard Mentor, Ohio 44060-4885
Re: K971275
Mill-Rose Disposeble Polypectomy Snare . . . . . . . Dated: April 4, 1997 Received: April 7, 1997 Regulatory class: II 21 CFR §876.4300/Product code: 78 FDI
Dear Mr. Poje:
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 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 regulations.
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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,
Lillian Yia, Ph.D.
Lillian Yin, Ph.D Director, Division of Reproduct Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page_ 1_ of __________________________________________________________________________________________________________________________________________________________________
K971275 510(k) Number (if known):
Mill-Rose Disposable Polypectomy Snare Device Namc:
Indications for Use:
The intended use of this device is to electro surgically remove GI tract polype _ through the channel of an endoscope.
(PI.F.A.S. DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEDDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Robert P. Salling/ | |
|---|---|
| (Division Sign-Off) |
Division of Reproductive, Abdominal, ENT,and Radiological Devices
510(k) Number K971275
Prescription Use_ (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Formal 1-2-96)