(22 days)
The intended use for the Cobra Surgical Probes is as follows:
The Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
The Cobra Surgical Probes are Electrosurgical Probes, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The system is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedure.
This submission describes a Special 510(k) for the Cobra Surgical Probes, which are electrosurgical probes used for the coagulation of cardiac and soft tissues. The submission asserts substantial equivalence to the previously cleared Cobra Surgical Probe (K013873).
Here's an analysis based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics. Instead, it relies on a comparison to a predicate device and a general statement about non-clinical testing.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Design-Input Criteria Met | "non-clinical tests conducted for the Device showed the device met its design-input criteria" |
| Safety Profile | "non-clinical tests conducted for the Device showed the device...was safe for its intended use" |
| Effectiveness for Intended Use | "non-clinical tests conducted for the Device showed the device...was effective for its intended use" |
| Compliance with GLP | "Where appropriate, testing conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP))" |
| Intended Use Match | The intended use for the modified device is identical to the predicate device. |
| Device Characteristics Match | All key device characteristics (Manufacturer, Device Description, Regulatory Class, Device Classification, Intended Use, Mode, Single Use?, EO Sterilized?, Shaft Size, Tip Material, Length, Electrode Size, Electrode Number) are "Same" as the predicate device. |
2. Sample Sizes and Data Provenance
The document does not specify sample sizes used for any test sets, nor does it provide details on data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is "non-clinical tests," which typically refers to bench or animal testing rather than human clinical data.
3. Number of Experts and Qualifications for Ground Truth
The document makes no mention of expert involvement in establishing ground truth for any test set. The evaluation is based on non-clinical testing and comparison to a predicate device.
4. Adjudication Method
There is no mention of an adjudication method as the evaluation is based on non-clinical testing and comparison to a predicate device, not expert review of cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed or mentioned in the document. The submission focuses on non-clinical testing and substantial equivalence to a predicate device, not on evaluating the improvement of human readers with AI assistance.
6. Standalone Performance Study
A "standalone" performance study in the context of an algorithm (i.e., algorithm only without human-in-the-loop performance) is not applicable here as the device is a physical electrosurgical probe, not an AI algorithm. The document states "non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use," which pertains to the device's functional performance in isolation.
7. Type of Ground Truth Used
The "ground truth" for this medical device submission appears to be based on:
- Design-input criteria: The device's performance was measured against its established design specifications.
- Safety and effectiveness benchmarks: Established through non-clinical testing, likely involving simulations, bench testing, and potentially animal studies (though not explicitly detailed beyond "non-clinical tests").
- Predicate device characteristics and performance data: The modified device's characteristics and intended use are directly compared to a legally marketed predicate device (K013873).
There is no mention of pathology, outcomes data, or expert consensus in relation to human clinical cases for defining ground truth in this document.
8. Sample Size for the Training Set
No training set is mentioned or applicable here, as the device is a physical electrosurgical probe and not an AI or machine learning algorithm.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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SPECIAL 510(K) SUBMISSION Cobra Surgical Probes
510(k) Summary of Safety and Effectiveness 3.
a. General Information
Modified Device Information
| Category: | Comments: |
|---|---|
| Sponsor: | Boston Scientific Corporation2710 Orchard ParkwaySan Jose, Ca 95134 |
| Correspondent: | April I. MalmborgSenior Specialist, Regulatory AffairsBoston Scientific Corporation2710 Orchard ParkwaySan Jose, Ca 95134 |
| Contact Information: | E-mail: malmbora@bsci.comPhone: (408) 895-3637Fax: (408) 895-2202 |
| Device Common Name: | Electrosurgical Probe |
| Device Proprietary Name: | Cobra Surgical Probe |
| Device Classification: | 21 CFR §878.4400 |
Predicate Device Information h.
| Predicate Device: | Cobra Surgical Probe (K013873) |
|---|---|
| Predicate Device Manufacturer: | Boston Scientific Corporation |
| Predicate Device Common Name | Electrosurgical Probe |
| Predicate Device Classification: | 21 CFR §878.4400 |
| Predicate Device Classification Number: | Class II |
Confidential
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Page ② of ③
Date Summary Prepared C.
January 30, 2004
d. Description of Device
The Cobra Surgical Probes are Electrosurgical Probes, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The system is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedure.
Intended Use e.
The intended use for the Cobra Surgical Probes is as follows:
The Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
Comparison to Predicate Device f.
See Table I- Comparison of Device Characteristics to Predicate on the following page.
Confidential
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Page ③ 3 ③
| Cobra® Surgical Probe(s) | Cobra® SurgicalProbe(s) | |
|---|---|---|
| Device Manufacturer& Name | Boston Scientific Corporation | Same |
| Device Description | Electrosurgical Probe | Same |
| 510(k) Number | K013873 | TBD |
| Regulatory Class | II | Same |
| Device Classification | 21 CFR §878.4400 | Same |
| Intended Use | Coagulation of Cardiac Tissueduring Cardiac surgery and SoftTissue during General OpenSurgical Procedures | Same |
| Mode(s) | Monopolar | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Shaft Size | 8F | Same |
| Tip Material | Stainless Steel | Same |
| Length | 15cm-35cm | Same |
| Electrode Size | 6mm to 12.5 mm | Same |
| Electrode Number | 2 to 7 | Same |
Table 1 - Comparison of Device Characteristics to Predicate
Summary of the Non-clinical Data g.
Where appropriate, testing conformed to the requirements of 21 CTR Part 58 (Good Laboratory Practices (GLP)). Specifically, non-clinical tests conducted for the Device showed the device met its design-input criteria, and was safe and effective for its intended use.
Confidential
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing protection and care. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is simple, using only black and white, and is designed to be easily recognizable.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Ms. April M. Malmborg Senior Specialist, Regulatory Affairs 2710 Orchard Parkway San Jose, CA 95134
Re: K040219
Trade/Device Name: Cobra Surgical Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II (two) Product Code: OCL, GEI Dated: January 30, 2004 Received: February 2, 2004
Dear Ms. Malmborg:
This letter corrects our substantially equivalent letter of February 24, 2004.
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 (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.
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Page 2 - Ms. April M. Malmborg
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.
This letter will allow you to continue marketing your device as described in your Section 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
El. Mall
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Premarket Notification -Indication for Use Statement
KO40219
Device Name:
Cobra Surgical Probes
Indication for Use:
The intended use for Cobra Surgical Probes is as follows:
The Probe is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR Over-the-Counte
(Per 21 CFR §801109)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number. K040219
Boston Scientific Corporation Special 510(k) Submission
CONFIDENTIAL
§ 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.