(88 days)
Not Found
No
The description focuses on the physical design and function of a stimulating probe tip and control handle, with no mention of data processing, algorithms, or learning capabilities.
No.
The device is described as a "surgical aid" to help physicians locate nerves during surgery; it does not directly treat a disease or condition.
No
The device is described as an "accessory stimulating tip" that aids the physician in "locating these nerves" through stimulation. It is used in surgical procedures and is designed as an "adjunct" to nerve-sparing techniques, not to diagnose a condition. Its purpose is to help the surgeon identify nerve locations during an operation, which is a surgical aid function rather than a diagnostic one.
No
The device description explicitly details physical hardware components, including a surgical stainless steel probe tip, insulating tubing, and a reusable control handle. It does not describe a software-only product.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Surgical Aid" used for "stimulation of the cavemosal and associated parasympathetic nerves during open or laproscopic prostatectorny, prostate brachytherapy placement, prostate cryotherapy, and open colorectal (surgical) procedures in males." It aids the physician in "locating these nerves."
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with the patient's nerves during a surgical procedure.
Therefore, the Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal Tip and its system are surgical devices used for nerve stimulation and localization during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
The Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal Tip is an accessory stimulating tip to be used for a perineal approach to nerve stimulation. It is an addition to the Blue Torch Medical Technologies CaverMap® Surgical Aid System. The system is indicated for use in the stimulation of the cavemosal and associated parasympathetic nerves during open or laproscopic prostatectorny, prostate brachytherapy placement, prostate cryotherapy, and open colorectal (surgical) procedures in males. The device aids the physician in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy, prostate brachytherapy placement, prostate cryotherapy, 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 physician's skill determines whether these nerves are spared regardless of any aid.
Product codes (comma separated list FDA assigned to the subject device)
77 ETN, 78 FGM
Device Description
The CaverMap Surgical Aid Perineal Tip has been designed specifically for use during perineal radical prostatectomy, prostate brachytherapy, and prostate cryotherapy procedures, where a nerve sparing technique is employed.
The perineal probe tip is designed as a single electrode made from surgical stainless steel. The probe tip is encapsulated in dielectrical insulating tubing, with the exception of the tip which is exposed to deliver the stimulation to the nerves. The tip also includes graduated length markings below the insulating tubing. The surface area of the stimulating (exposed) trocar tip is the same as the current electrodes of the currently marketed probe tip, giving the electrode the same charge density profile as the currently marketed probe tips.
A new reusable control handle was also designed in order to allow for a proper connection to the new probe tip. The materials used to manufacture the new handle are exactly the same as the currently marketed product.
The perineal probe tip functions exactly the same as the existing probe tip. The new tip was designed for use during nerve sparing procedures where a perineal approach to stimulating the cavernosal nerves is indicated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cavemosal and associated parasympathetic nerves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / open or laproscopic prostatectorny, prostate brachytherapy placement, prostate cryotherapy, 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): 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
§ 876.4730 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
K041732
page 1 of 2
SEP 2 1 2004 510(k) Summary of Safety and Effectiveness Blue Torch Medical Technologies CaverMap Surgical Aid Additional Perineal Tip
Company Name
Blue Torch Medical Technologies
Official Contact
Frederick Tobia
Device Name
| Proprietary Name: | Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal
Tip |
|-------------------------|---------------------------------------------------------------------------------------------|
| 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 Perineal Tip is an accessory stimulating tip to be used for a perineal approach to nerve stimulation. It is an addition to the Blue Torch Medical Technologies CaverMap® Surgical Aid System. The system is indicated for use in the stimulation of the cavemosal and associated parasympathetic nerves during open or laproscopic prostatectorny, prostate brachytherapy placement, prostate cryotherapy, and open colorectal (surgical) procedures in males. The device aids the physician in locating these nerves. The device is designed as an adjunct to the current open or laproscopic prostatectomy, prostate brachytherapy placement, prostate cryotherapy, 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 physician's skill determines whether these nerves are spared regardless of any aid..
PAGE 30 OF 36 510(K) CAVERMAP SURGICAL AID PERINEAL TIP
1
K041732
Page 2 of 2
Description
The CaverMap Surgical Aid Perineal Tip has been designed specifically for use during perineal radical prostatectomy, prostate brachytherapy, and prostate cryotherapy procedures, where a nerve sparing technique is employed.
The perineal probe tip is designed as a single electrode made from surgical stainless steel. The probe tip is encapsulated in dielectrical insulating tubing, with the exception of the tip which is exposed to deliver the stimulation to the nerves. The tip also includes graduated length markings below the insulating tubing. The surface area of the stimulating (exposed) trocar tip is the same as the current electrodes of the currently marketed probe tip, giving the electrode the same charge density profile as the currently marketed probe tips.
A new reusable control handle was also designed in order to allow for a proper connection to the new probe tip. The materials used to manufacture the new handle are exactly the same as the currently marketed product.
The perineal probe tip functions exactly the same as the existing probe tip. The new tip was designed for use during nerve sparing procedures where a perineal approach to stimulating the cavernosal nerves is indicated.
Summary of Standards Achieved
FDA Quality Systems Regulation 21 CFR § 820 ISO 46001: Quality System EN 60601-1 ISO 10993
Summary
In summary, the Blue Torch Medical Technologies CaverMap Surgical Aid Perineal Tip 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 an eagle or bird with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
SEP 2 1 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Frederick Tobia Regulatory Consultant Blue Torch Medical Technologies, Inc. 200 Homer Avenue Ashland Technical Center ASHLAND MA 01721
Re: K041732
Ro41732
Trade/Device Name: Blue Torch Medical Technologies CaverMap Surgical Aid Perineal Probe Tip Regulation Number: 21 CFR §874.1820 Regulation Name: Surgical nerve stimulator/locator Product Code: 77 ETN Regulation Number: 21 CFR §876.4730 Regulation Name: Manual gastroenterology-urology surgical instrument and accessories Product Code: 78 FGM Regulatory Class: II Dated: August 23, 2004 Received: August 25, 2004
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, 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 (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 (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.
3
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to obgin maining of substantial equivalence of your device to a legally prematication. The PDF mailing of and in the 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 advice for your de of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 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 Additionally, 101 questions on the process. Also, please note the regulation entitled, "Misbranding Onlice of Complance at (2017 27) 21 11 (21 CFR Part 807.97) you may obtain. Other general by relevence to premarked nonmoution (er the Act may be obtained from the Division of Small Information on your responsionalist and Consumer Assistance at its toll-free number (800) 638-2041 or Manblacturers, International and Solass
(301) 443-6597 or at its Internet address http://www.fda.gov/cdch/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
Page _
510(k) Number (if known):
Device Name:
Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal Probe Tip
Indications for Use: The Blue Torch Medical Technologies CaverMap® Surgical Aid Perineal Tip is an accessory stimulating tip to be used for a perineal approach to nerve stimulation. It is an is all accessory of manang Medical Technologies CaverMap® Surgical Aid System. The system is indicated for use in the stimulation of the cavemosal and associated parasympathetic nerves during moreated for are in the outsecures, prostate brachytherapy placement, prostate cryotherapy, and open of laptoseopic producedem), provenles. The device aids the physician in locating these nerves open colored is designed as an adjunct to the current open or laproscopic prostatectomy, prostate I he uctier is deagered as arraste cryotherapy, and open colorectal procedures in which a nerve oracing technique is used. The Surgical Aid is not designed to replace the surgeon's expertise in sparing to the neurovascular bundles. Each physician'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)
PAGE 35 OF 36
OR
Over-The-Counter Use__
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K041737
CAVERMAP SURGICAL AID PERINEAL TIP