(78 days)
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Not Found
No
The summary describes a radio frequency generator for cutting and coagulating soft tissue, with no mention of AI, ML, image processing, or data-driven features.
Yes
The device is used to cut and coagulate soft tissue in general surgical procedures, which are therapeutic interventions.
No
The device is described as a "Radio Frequency Perforation Generator" indicated for "cut and coagulate soft tissue" in "general surgical procedures." These functions are therapeutic, not diagnostic.
No
The device is described as a "Radio Frequency Perforation Generator" with model numbers, indicating it is a hardware device that generates radio frequency energy for surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to cut and coagulate soft tissue in general surgical procedures." This describes a device used on the patient's body during surgery, not a device used to test samples outside the body (in vitro).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
Therefore, the BMC Radio Frequency Perforation Generator is a surgical device, not an in vitro diagnostic device.
No.
There is no mention of a Predetermined Change Control Plan (PCCP) in the provided letter. PCCPs are specifically authorized and would be explicitly stated if applicable, often in sections related to modifications or future changes to AI/ML software.
Intended Use / Indications for Use
The BMC Radio Frequency Perforation Generator, Model RFP-100-115 (For Domestic Use) and Model RFP-100-230 (For International Use) is indicated for use in general surgical procedures to cut and coagulate soft tissue.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 2002
Mr. Kris Shah Vice-President, Product Development Baylis Medical Company, Inc. 5160 Explorer Drive, Unit 33 Mississauga, Ontario L4W 4T7 Canada
Re: K013904
Trade Name: BMC Radio Frequency Perforation Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Regulatory Class: II Product Code: GEI Dated: November 19, 2001 Received: November 26, 2001
Dear Mr. Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bourse et ermined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to Indications for use stated in the ensires of the Medical Device Amendments, or to devices that have May 26, 1970, the chacement date 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 therefore, marker the devices to expect to equirements for annual registration, listing of devices, controls provisions or the recements square squares misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it II your device is classifica (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations and may be subject to such additional controliations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I outstal Integraing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oe advised that I Dri 3 ibsounce or our device complies with other requirements of the Act that IDA has made a decommandions administered by other Federal agencies. You must of any Federal statutes and regulations administred to: registration and listing (21 comply with an the Hot of requirements, and manufacturing practice requirements as set CITY at 807), adomig (21 OFRT arrown), good if god if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Page 2 - Mr. Kris Shah
This letter will allow you to begin marketing your device as described in your Section 510(k)
The first of the may of the of a local starticle spiralence of your device to le I his letter will anow you to begin makemily of substantial equivalence of your device to a legally premarket notification. The FDA iniding of substanted by and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFF Part 801 and If you desire specific advice for your do vited diagnostic devices), please contact the Office of additionally 21 CFR Part 809.10 till With Creenstions on the promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and adve Compliance at (301) 394-4037. Additionally, for quest.25 (594-4639. Also, please note the your device, prease comace the Office of eene to premarket notification (21CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification the regulation entitled, Millsoranding of references to proder the Act may be obtained from the Other general information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
uriam C. Provost
Por Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
013904
Page 1 of 1
um 510(k) Number (if known):
3 10(K) Nambor (1 1 1 - 1 - 1 - 1 - 1 - 1 - Frqeuency Perforation Generator
Device Name: _____________________________________________________________________________________
Indications For Use:
indications Por Use.
The BMC Radio Frequency Perforation Generator; Model RFP-100-115 (For Domestic Use) and The BMC Radio Frequency Perforation Generalor, Model REP-200-2007 (11:45)
Model RFP-100-230 (For International Use) is indicated for use in general surgical procedures to cu and coagulate soft tissue.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription use: X
(Optional Format 3-10-98)
Muriam C. Provost
sion Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number K013904