(129 days)
Not Found
Not Found
No
The provided text describes a thermal scalpel system that uses heat for cutting and sealing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the physical mechanism of action (heat conduction) and its intended surgical benefits.
Yes
The device is a surgical instrument that seals blood vessels using heat, directly acting on the body for a medical purpose (minimizing blood loss).
No
The device is described as a surgical instrument designed to minimize blood loss during surgery by sealing blood vessels with heat. It is an operative tool, not a diagnostic one.
No
The device description clearly states it is a "surgical instrument" and a "Thermal Scalpel System" that uses an "elevated-temperature blade" to cut and seal tissue, indicating it is a hardware device.
Based on the provided information, the Hemostatix Model 2400Z Scalpel System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the Hemostatix Model 2400Z is a surgical instrument used to cut and seal blood vessels during surgery. It operates directly on tissue within the body (in vivo), not on samples outside the body (in vitro).
The information provided focuses on the surgical function of the device and its mechanism of action (thermal cutting and sealing), which are characteristic of surgical instruments, not IVDs.
N/A
Intended Use / 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.
Product codes
GEI
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
Oximetrix Shaw Hemostatic Surgical System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 System
Thermal Scalpel
Electrosurgical cutting and coagulation device and
accessories (§ 874.4400) |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Gregory Sredin
Manager of Regulatory Affairs
Gyrus ENT
2925 Appling Road
Bartlett, 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.
1
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.
2
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
3
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
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