(510 days)
No
The summary describes a plasma coagulation system based on electrical and gas dynamics, with no mention of AI or ML components for data analysis, decision-making, or control.
Yes
The device is described as a "neutral plasma coagulator that is designed for coagulation in open surgery and laparoscopic surgery," directly indicating its use in treating a medical condition (bleeding).
No
Explanation: The device is described as a "neutral plasma coagulator" used for "coagulation," and its function involves heat dissipation to cause coagulation and seal tissue to prevent bleeding. There is no mention of diagnostic capabilities; its purpose is therapeutic (coagulation).
No
The device description clearly outlines hardware components including handpieces, a console, a footswitch, and a service module, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation in open surgery and laparoscopic surgery." This describes a surgical procedure performed directly on the patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details a system that generates a plasma jet to interact with tissue for coagulation. This is a therapeutic or surgical device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, disease, or condition based on sample analysis.
- Using reagents or assays.
The PlasmaJet™ System is clearly a surgical tool used for hemostasis during procedures.
N/A
Intended Use / Indications for Use
The PlasmaJet™ System is a neutral plasma coagulator that is designed for coagulation in open surgery and laparoscopic surgery.
Product codes
GEI
Device Description
The PlasmaJet™ system consists of a range of single-use open or laparoscopic handpieces that are assured for obagains, in and argon plasma. A console is used to power the handpiece and a footswitch and a service module (providing a used to power the handplose for an argon tank) completes the system.
In the PlasmaJet™ system, as in a bipolar electrosurgery system, both anode and cathode used to generate the argon partic plasma are contained within the handpices, and no ground plate is used. "Decated bour the patient and no more of alternate the liandpiece there is no carrent no niece, a specially designed series of electrodes site burns. In the PlasmaJet™ handpiece, a specially designed series and allows a relatively low voltage (of about 30V) to generate a more energetic and allows a relatively 101. PlasmaJet™ plasma uses a much lower flow of argon gas than is used in the argon I lasmarco - Plasma Coagulator, the plasma is crocere....) electrically neutral and comprises a mixture of excited argon atoms, argon ions, and electrons that emerge from the tip of the handpiece in an intense pale blue jet or beam.
When the plasma jet reaches the bleeding tissue, it gives up its kinctic energy as heat which the plasma fer reasies in the bleeding surface by a series of processes. First, the allu causes coaganacon of the broom of argon plasma removes liquid blood from the tissue surface or vessel. Secondly, the energy dissipated from the plasma to the tissue ussuc surface of recom of corm a series of layers of eschar that seal the tissue surface and prevent further bleeding.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Animal and clinical studies conventional ciccurosurgery of arget stablished that the neutral plasma coagulator have been pore effective coagulation than the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
AUG - 5 2004
Page ① of 2
KO30819
510(k) Summary
October 30th 2003
Submitter 1
Plasma Surgical Ltd First Floor Albemarle House 1 Albemarle Street London W1X 3HF United Kingdom
| Contact Person: | Prof. Peter F Gibson |
|---|---|
| Telephone: | +44 1264 711080 |
| Facsimile: | +44 1264 711083 |
| E-mail: | petergibson@plasmasurgical.co.uk |
Name of Device 2
| Proprietary Name: | PlasmaJet™ system, comprising:
a) PlasmaJet™ console
b) PlasmaJet™ service module
c) PlasmaJet™ open surgery handpieces
d) PlasmaJet™ laparoscopic surgery handpieces |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Neutral Plasma Coagulator |
| Device Classification: | Electrosurgical coagulation devices have been placed in Class
II as per 21 CFR Regulation Number 878.4400 and assigned
the Product Code GEI. |
Predicate Devices 3
The components of the PlasmaJet™ system are substantially equivalent to the following legally marketed devices:
| K871435 | Bard EMS System 6000 |
|---|---|
| K904545 | Valleylab Force GSUTM System / Force GSU™ Handset |
| K963189 | Erbe APC300 Argon Plasma Coagulator and Accessories |
This statement is based on the similarity of the subject device to the predicate I his statement is bases exaterials, design and principles of operation.
1
Device Description 4
The PlasmaJet™ system consists of a range of single-use open or laparoscopic The Plasmajer - system consisted of a carea. In and argon plasma. A console is nandpieces that are assured for obagains.
used to power the handpiece and a footswitch and a service module (providing a used to power the handplose for an argon tank) completes the system.
In the PlasmaJet™ system, as in a bipolar electrosurgery system, both anode and In the Plasmajet - System, as in a spissma are contained within the handpices, and cathode used to generate the argon partic no ground plate is used. "Decated bour the patient and no more of alternate the liandpiece there is no carrent no niece, a specially designed series of electrodes
site burns. In the PlasmaJet™ handpiece, a specially designed series and allows a relatively low voltage (of about 30V) to generate a more energetic and allows a relatively 101. PlasmaJet™ plasma uses a much lower flow of argon gas than is used in the argon I lasmarco - plasma ases a mis electrically neutral and comprises a mixture of excited Deall Coagulator, the plasma is crocere....)
argon atoms, argon ions, and electrons that emerge from the tip of the handpiece in an intense pale blue jet or beam.
When the plasma jet reaches the bleeding tissue, it gives up its kinctic energy as heat which the plasma fer reasies in the bleeding surface by a series of processes. First, the allu causes coaganacon of the broom of argon plasma removes liquid blood from the tissue surface or vessel. Secondly, the energy dissipated from the plasma to the tissue ussuc surface of recom of corm a series of layers of eschar that seal the tissue surface and prevent further bleeding.
Intended Use 5
The PlasmaJet™ system is a neutral plasma coagulator that is designed for coagulation in open surgery and laparoscopic surgery.
Summary of Substantial Equivalence 6
The PlasmaJet™ system is similar in design, intended use and performance The Flashajet - System is sammar ines. It differs in combining the electrodes used to characterisues to the predicate the handpiece, and does not require the use of an electrosurgical grounding plate, nor does a current pass through the patient as in conventional electrosurgery or argon beam coagulation. Animal and clinical studies conventional ciccurosurgery of arget stablished that the neutral plasma coagulator have been pore effective coagulation than the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 5 2004
Professor Peter F. Gibson Plasma Surgical Ltd First Floor Albemarle House 1 Albemarle Street London W1X 3HF United Kingdom
Re: K030819
Trade/Device Name: PlasmaJet™ System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 25, 2004 Received: May 27, 2004
Dear Professor Gibson:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premained homeon (tor the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the clebosure) to regally mannet date of the Medical Device American be and Ford. For d. Ford, Drug commerce prof to May 20, 1976, the enature with the provisions of the Federal Food, Drug, devices that have been recalismed in acceracy val of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli and Cosment Act (Act) that do not require approvine controls provisions of the Act. The You may, therefore, market the devices, books of the more of registration, listing of general controls provisions of the free hoteling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is crassified (sociation major regulations affecting your device can
may be subject to such additional controls. Existing major regulations EDA move may be subject to such additional controller in the 21, Parts 800 to 898. In addition, FDA may be found in the Out of Peach oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuance of a based in a complies with other requirements of the Act that FDA has made a decermination that Jour Secret by other Federal agencies. You must or any Federal statutes and regarations annuding, but not limited to: registration and listing (21 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFK Part 607), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
3
Page 2 - Professor Peter F. Gibson
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin hankemig your avince of your device of your device to a legally premarket notification. The FDA mining of substantial organisation of your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s an interest of the may not a come of the collection antiled If you desire specific advice for your de rice of var accesse note the regulation entitled, and comact the Office of Complaned at (301) 37 - 40 m (21CFR Part 807.97). You may obtain "Misbranding by relefence to premantee nowlite as and released on the Division of Small other general mioritation on your responsion.com its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance of Armanaio Attril Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia 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
4
Indications for Use
510(k) Number (if Known): K030819
PlasmaJet™ System Device Name:
The PlasmaJet™ System is a neutral plasma Indications for Use: THC Placmator that is designed for coagulation in open surgery and laparoscopic surgery.
X = Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFGR 801 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
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K030819