(21 days)
Not Found
No
The description focuses on a video monitor displaying data from a control unit via an RS-232 port, with no mention of AI, ML, or related concepts.
No.
The device is described as a "Surgical Aid" that helps the surgeon locate nerves and displays data. It is not designed to treat a condition or restore function, but rather to assist in a surgical procedure.
No
The device is described as a "Surgical Aid" that "aids the surgeon in locating these nerves." It displays data and does not independently diagnose a condition or disease.
No
The device description explicitly states it consists of a self-contained IBM compatible computer system with an integrated liquid plasma video screen, which are hardware components.
Based on the provided information, the Blue Torch Medical Technologies CaverMap® Surgical Aid Video Monitor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The CaverMap® Surgical Aid Video Monitor is a surgical aid used during surgical procedures (prostatectomy and colorectal surgery) to help the surgeon locate nerves. It works by displaying data from a control unit that likely interacts directly with the patient's body (stimulation of nerves).
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It is used in real-time during surgery.
Therefore, the device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Intended Use: The Blue Torch Medical Technologies CaverMap Surgical Aid is intended to provide stimulation to the body to locate and identify nerves and to test their excitability.
Indications for Use: The Blue Torch Medical Technologies CaverMap® Surgical Aid Video Monitor is a modification to the Blue Torch Medical Technologies CaverMap® Surgical Aid System is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open or laproscopic prostatectomy and open colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy and open colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid.
Product codes
77 ETN, 78 FGM
Device Description
The CaverMap Surgical Aid Monitor consists of a self contained IBM compatible computer system with an integrated liquid plasma video screen. The integrated video display unit will be connected to the CaverMap Surgical Aid Control unit by a standard RS-232 port.
The CaverMap Surgical Aid Monitor reads data directly from the CaverMap Surgical Aid Control Unit through a RS232 port, which will be a modification to the current control unit design. The video monitor displays the data to the video screen in text and graphical format. Communication between the CaverMap Surgical Aid and the CaverMap Surgical aid Monitor is unidirectional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cavernosal and associated parasympathetic nerves.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon / open or laproscopic prostatectomy and open colorectal (surgical) procedures
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)
Blue Torch Medical Technologies CaverMap Surgical Aid K970971
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.4730 Manual gastroenterology-urology surgical instrument and accessories.
(a)
Identification. A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop. A manual surgical instrument that is intended specifically for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures are classified under § 884.4910 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows a sequence of alphanumeric characters, specifically "KO31527". The characters are handwritten in a dark ink, and they appear to be a combination of uppercase letters and numbers. The characters are written in a clear and legible manner.
JUN - 5 2003
510(k) Summary of Safety and Effectiveness Blue Torch Medical Technologies® CaverMap Surgical Aid With Video Monitor
Company Name
Blue Torch Medical Technologies® Corporation
Official Contact
Frederick Tobia Director, Regulatory Affairs and Quality Assurance
Device Name
| Proprietary Name: | Blue Torch Medical Technologies CaverMap® Surgical Aid with Video
Monitor |
|-------------------------|---------------------------------------------------------------------------------------------|
| Common Name: | Nerve Stimulator/Locator |
| Classification Name(s): | 21 CFR § 874.1820 Stimulator, Nerve
21 CFR § 876.4730 Probe And Director, Gastro-Urology |
Predicate Devices used for Substantial Equivalence
Blue Torch Medical Technologies CaverMap Surgical Aid K970971
Intended Use
The Blue Torch Medical Technologies CaverMap Surgical Aid is intended to provide stimulation to the body to locate and identify nerves and to test their excitability.
Indications for Use
The Blue Torch Medical Technologies CaverMap® Surgical Aid Video Monitor is a modification to the Blue Torch Medical Technologies CaverMap® Surgical Aid System is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open or laproscopic prostatectomy and open colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy and open colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid..
Description
The CaverMap Surgical Aid Monitor consists of a self contained IBM compatible computer system with an integrated liquid plasma video screen. The integrated video display unit will be connected to the CaverMap Surgical Aid Control unit by a standard RS-232 port.
1
The CaverMap Surgical Aid Monitor reads data directly from the CaverMap Surgical Aid Control Unit through a RS232 port, which will be a modification to the current control unit design. The video monitor displays the data to the video screen in text and graphical format. Communication between the CaverMap Surgical Aid and the CaverMap Surgical aid Monitor is unidirectional.
The information displayed is:
- Tumescence Signal
- Baseline and Threshold Tumescence Signals ●
- Status Indication
- Stimulation Current.
- Time and Seconds Counter
- Error Messages
Summary of Standards Achieved
FDA Quality Systems Regulation 21 CFR § 820 ISO 46001: Quality System EN 60601-1
Summary
In summary, the Blue Torch Medical Technologies CaverMap Surgical Aid Video Monitor is substantially equivalent to legally marketed devices. Quality System & Design Controls assure the device is substantially equivalent to the predicate devices with respect to its performance, safety, and effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, with the top profile being the most complete and the bottom profile being the least complete. The seal is black and white.
ر Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Blue Torch Medical Technologies, Inc. c/o Mr. Frederick Tobia Director, RA/ QA CareStat 180 Wells Avenue NEWTON MA 02459
Re: K031527
Trade/Device Name: CaverMap® Surgical Aid with Video Monitor Regulation Number: 21 CFR §874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: II Product Code: 77 ETN Regulation Number: 21 CFR §876.4730 Regulation Name: Manual gastroenterology-urology surgical instrument and accessories Regulatory Class: I Product Code: 78 FGM Dated: May 8, 2003 Received: May 21, 2003
JUN - 5 2003
Dear Mr. Tobia:
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. Iisting 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 (PMA), it may be subject to 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4592 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsmaldsmamain.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
4
1 _ of _ 1 _ Page _
K03 510(k) Number (if known):
Device Name:
Blue Torch Medical Technologies CaverMap® Surgical Aid
Indications for Use: The Blue Torch Medical Technologies CaverMap® Surgical Aid Video Monitor is a modification to the Blue Torch Medical Technologies CaverMap® Surgical Aid System. The system is indicated for use in the stimulation of the cavernosal and associated parasympathetic nerves during open or laproscopic prostatectomy and open colorectal (surgical) procedures in males. The device aids the surgeon in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectorny and open colorectal procedures in which a nerve sparing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in mapping out the neurovascular bundles. Each surgeon's skill determines whether these nerves are spared regardless of any aid..
(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 |
|---|---|---|---|
| ------------------------------------------- | --------------------------------------------------- | ---- | ------------------------------------------------------------------------ |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K031527 |
|---|---|
| --------------- | --------- |
PAGE 38 OF 38 SPECIAL 510(K) CAVERMAP SURGICAL AID WITH VIDEO MONITOR