(129 days)
The Hemostatix Model 2400Z Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
The Hemostatix Model 2400Z Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
This 510(k) summary does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance. This document primarily focuses on establishing substantial equivalence to a predicate device and outlining basic device characteristics and regulatory compliance.
Here's an breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document states that "The Hemostatix Model 2400Z Thermal Scalpel System is designed to meet UL 2601-1 including Australian deviations, CSA 22.2 No. 601, IEC 601-1-1 (EN 60601-1), IEC 601-1-2 (EN 60601-1-2), IEC 601-1-4 (EN 60601-1-2), IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 529, ISO 10993-1, EN 55011, Class B."
This lists a set of international and national standards that the device is designed to meet. However, it does not provide specific performance metrics or acceptance criteria tables as they would typically be presented (e.g., minimum cutting efficiency, maximum tissue damage, etc.). It also does not report detailed performance results against these standards, only a general statement of compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given text. There is no mention of any specific test sets, sample sizes, or data provenance from a device performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided. The document does not describe any studies involving experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. As there's no mention of a test set or ground truth establishment, there's no adjudication method described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is a "Thermal Scalpel System," not an AI-assisted diagnostic or imaging system that would typically involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a surgical instrument. There is no mention of an algorithm in the context of performance studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not provided. No specific performance study with ground truth is described. The approval is based on "substantial equivalence" to a predicate device and compliance with general safety and performance standards.
8. The sample size for the training set:
This information is not provided. No training set for an algorithm is mentioned or relevant to this type of device and submission.
9. How the ground truth for the training set was established:
This information is not provided. No training set for an algorithm is mentioned or relevant to this type of device and submission.
Summary based on available information:
The provided document, a 510(k) summary, focuses on establishing the substantial equivalence of the "Hemostatix Model 2400Z Thermal Scalpel System" to a predicate device (Oximetrix Shaw Hemostatic Surgical System) and its intended compliance with various technical and safety standards. It does not present a detailed study with specific acceptance criteria, performance metrics, or clinical data in the format you requested. The regulatory approval is based on demonstrating that the new device has "the same technological characteristics, power modality and mode of operation as the predicate device" and meets a list of recognized safety and performance standards, rather than a specific comparative effectiveness study with ground truth and expert evaluation.
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EB = 5 2004
KO33089 (pg 1 of 1 510(k) Summary of Safety and Effectiveness
| Trade Name:Common Name:Classification Name: | Hemostatix Model 2400Z Thermal Scalpel SystemThermal ScalpelElectrosurgical cutting and coagulation device andaccessories (§ 874.4400) |
|---|---|
| Official Contact: | Gregory SredinManager of Regulatory AffairsGyrus ENT2925 Appling RoadBartlett, TN 38133 |
| Telephone:Telefax: | (901) 373-0200(901) 387-3914 |
| Date Prepared: | September 19, 2003 |
The Hemostatix Model 2400Z Thermal Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
The Hemostatix Model 2400Z Thermal Scalpel System that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate device. The intended uses are substantially equivalent to the described predicate Oximetrix Shaw Hemostatic Surgical System. The Hemostatix Model 2400Z Thermal Scalpel System is designed to meet UL 2601-1 including Australian deviations, CSA 22.2 No. 601, IEC 601-1-1 (EN 60601-1), IEC 601-1-2 (EN 60601-1-2), IEC 601-1-4 (EN 60601-1-2), IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 529, ISO 10993-1, EN 55011, Class B.
The Hemostatix Model 2400Z Thermal Scalpel System is substantially equivalent to the Oximetrix Shaw Hemostatic Surgical System and the difference of the processors that control the units should not affect the safety or effectiveness of the device.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. Above the caduceus, the words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 5 2004
Mr. Gregory Sredin Manager of Regulatory Affairs Gyrus ENT LLC 2925 Appling Road Bartlett, Tonnessee 38133
Rc: K033089
Trade/Device Name: Hemostatix Model 2400Z Thermal Scalpel System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 21, 2004 Received: January 22, 2004
Dear Mr. Sredin:
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 Cl·R 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.
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Page 2 - Mr. Gregory Sredin
This letter will allow you to begin 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
forCelia 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
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Indications for Use
510(k) Number: K033089
Device Name: Hemostatix Model 2400Z Thermal Scalpel System
Indications For Use:
The Hemostatix Model 2400Z Scalpel System is a surgical instrument designed to retain the precise, clean cutting characteristics of the traditional steel scalpel and to minimize blood loss by simultaneously sealing blood vessels as they are cut, with minimum tissue damage and virtually no muscle stimulation, using heat thermally conducted to the tissue from an elevated-temperature blade.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C Provost
· ivision Sign-Off) Oivision of General, Restorative Neurological Devices
Page 1 of 1
§ 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.