(15 days)
Not Found
No
The summary describes a standard electrosurgical device that uses radiofrequency energy for coagulation, with no mention of AI or ML in its function, description, or performance studies.
No.
The device is used to coagulate soft tissues and blood for hemostasis during surgical procedures, which are interventional actions rather than therapeutic in nature.
No
Explanation: The device is intended for coagulation of tissues and blood during surgical procedures (therapeutic), and is not described as being used to diagnose conditions or diseases.
No
The device description explicitly states it is a "sterile, single use electrosurgical device" and describes physical components like electrodes, an instrument cable, and a probe, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for coagulating soft tissues and blood during surgical procedures under direct visual control of a physician. This is a therapeutic/surgical intervention performed directly on the patient's body.
- Device Description: The device transmits radiofrequency energy to the tissue. This is a physical interaction with the tissue, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on a specimen.
Therefore, this device falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Probe is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissues to produce hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Boston Scientific Corporation Surgical Probe is a sterile, single use electrosurgical device intended to be used to coagulate soft tissues. The surgical probe transmits radiofrequency energy from electrodes which are connected to an Electrosurgical unit (non-sterile; re-useable) through an Instrument Cable (sterile; re-useable).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; open, general 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)
Specifically, non-clinical tests conducted for the Device included Fluid Path Integrity, Bond Joint Tensile Strength, Bond Joint Torsional Strength, Distal Section Fatigue, Shaft to Handle Tensile Strength, Biocompatibility and, both acute and chronic, In vivo performance.
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
§ 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
APR 1 6 2002
| Attachment 4
| 510(k) Summary | K021046 1/2 | |
|---|---|---|
| Category: | Comments | |
| Sponsor: | Boston Scientific Corporation | |
| 2710 Orchard Parkway | ||
| San Jose, CA 95134 | ||
| Correspondent: | Susan R. Pool | |
| Manager, Regulatory Affairs | ||
| 2710 Orchard Parkway | ||
| San Jose, CA 95134 | ||
| Contact Information: | E-mail: pools@bsci.com | |
| Phone: 408.895.3608 | ||
| Fax: 408.895.2202 | ||
| Device Common Name | Electrosurgical Probe | |
| Device Proprietary Name | Cobra® Cooled Surgical Probe | |
| Device Classification | 21 CFR § 878.4400, class II, product code GEI | |
| Predicate Device | Electrosurgical Probe | |
| Predicate Device Manufacturer(s) | Boston Scientific Corporation/EP | |
| Technologies, Inc. | ||
| Predicate Device Proprietary Name(s) | Cobra® Surgical Probe | |
| Predicate Device Classification Number | Class II | |
| Predicate Device Classification(s) | 21 CFR § 878.4400, product code GEI |
Date Summary Was Prepared:
March 28, 2002
Description of the Device:
The Boston Scientific Corporation Surgical Probe is a sterile, single use electrosurgical device intended to be used to coagulate soft tissues. The surgical probe transmits radiofrequency energy from electrodes which are connected to an Electrosurgical unit (non-sterile; re-useable) through an Instrument Cable (sterile; re-useable).
1
K021046 2/2
Intended Use:
The Probe is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissues to produce hemostasis.
Comparison to Predicate Device:
| Predicate Device | Modified Device | |
|---|---|---|
| 510(k) Reference | K981981; K010956 | Current Submission |
| Intended Use | Coagulation of tissue | Same |
| Device | ||
| Description | Electrosurgical Probe | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Manufacturer | Boston Scientific Corporation/EP | |
| Technologies, Inc. | Same | |
| Device | ||
| Classification | Class II, 21 CFR §878.4400, code | |
| GEI | Same |
Summary of the Non-clinical Data:
Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical tests conducted for the Device included Fluid Path Integrity, Bond Joint Tensile Strength, Bond Joint Torsional Strength, Distal Section Fatigue, Shaft to Handle Tensile Strength, Biocompatibility and, both acute and chronic, In vivo performance.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular pattern around an emblem. The emblem is a stylized representation of a human figure, with three abstract shapes forming the body and head, symbolizing health and human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 2002
Ms. Susan Pool Regulatory Manager Boston Scientific Corporation 2710 Orchard Parkway San Jose, CA 95134
Re: K021046
Trade/Device Name: Cobra Cooled Surgical Probe, Model 1596X Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 28, 2002 Received: April 1, 2002
Dear Ms. Pool:
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 such 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 - Ms. Susan Pool
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse of substantial equivalence of your device to a legally promatics notification: "The Pressification 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 If you desire specific ad roo for your witten diagnostic devices), please contact the Office of additionally 21 OF IC For 659. Additionally, for questions on the promotion and advertising of Compliance at (301) 594-1007 - 1007 - 1001) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). I cither general information on your responsibilities under the Act may be obtained from the Other general mionmator thernational 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,
Miriam C. Provost
Cor Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Attachment 2 Intended Use Statement
KO21046 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Cobra® Cooled Surgical Probe Device Name:
Indication for Use:
The Probe is intended for use only under direct visual control of the physician The I robe is incended for ass base of a coagulate soft tissues. The Probe during open, general bargical produce blood and soft tissues to produce hemostasis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR §801.109)
Over-
Over-the-Counter Use_
Muriam C. Provost
ion of General, Restorative Neurological Device
510(k) Number K021046
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