(138 days)
The PlasmaJet® system is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery.
The PlasmaJet® system comprises: a) PlasmaJet® console (Version 3-Plus), b) PlasmaJet® service module, c) PlasmaJet® open surgery handpieces, and d) PlasmaJet® laparoscopic surgery handpieces. It is a neutral plasma surgery system. The latest version of the PlasmaJet® console (Version 3-Plus) features rapidly pulsed plasma in a so-called "Ultra" mode that provides optimal cutting and coagulation capability.
The provided document is a 510(k) summary for the Plasma Surgical PlasmaJet® System (Version 3-Plus). This document focuses on demonstrating substantial equivalence to predicate devices for a surgical tool used for cutting, coagulation, and tissue vaporization. It does not describe a study involving acceptance criteria for a device performance that would typically be described by metrics like sensitivity, specificity, or F1-score, as these are usually associated with AI/ML-driven diagnostic or predictive devices.
Instead, the submission relies on pre-clinical and tissue studies to establish that the PlasmaJet® system provides safe and effective cutting, coagulation, and removal of soft tissue by vaporization, with minimal damage to underlying tissue, equivalent to predicate devices. The "acceptance criteria" in this context are implicitly that these studies confirm the new device's performance aligns with the established safety and effectiveness of its predecessors.
Therefore, many of the requested elements regarding sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable to this type of medical device submission.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safe and effective cutting, coagulation, and removal of soft tissue by vaporization | "Pre-clinical and tissue studies have been performed and these have established that the PlasmaJet® neutral plasma surgery system provides safe and effective cutting, coagulation and removal of soft tissue by vaporization equivalent to predicate devices with minimal damage to underlying tissue." |
| Minimal damage to underlying tissue | "Pre-clinical and tissue studies have been performed and these have established that the PlasmaJet® neutral plasma surgery system provides safe and effective cutting, coagulation and removal of soft tissue by vaporization equivalent to predicate devices with minimal damage to underlying tissue." |
| Equivalence to predicate devices (K080197, K031085, K100415) | The submission states the device is "identical in technological characteristics to the predicate PlasmaJet® device (K080197)" for the core system, and similar in action for cutting and removing tissue to the other predicates. The studies confirmed "equivalence to predicate devices." |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document mentions "Pre-clinical and tissue studies" but does not provide details on the number of tissue samples or subjects used in these studies.
- Data provenance: Not specified. This type of submission typically focuses on technical characteristics and comparative studies rather than clinical trial data provenance in the same way as an AI/ML device. The studies were likely conducted internally or by a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts and qualifications: Not specified. Ground truth for these types of "pre-clinical and tissue studies" would typically be established by laboratory analysis, histological examination, and potentially expert assessment of the surgical effect by veterinarians or specialized pathologists, but no details are provided.
4. Adjudication method for the test set
- Adjudication method: Not applicable. This concept is typically relevant for studies where multiple human readers assess data independently and discrepancies need to be resolved. For pre-clinical and tissue studies, the "ground truth" is derived from direct experimental observation and analysis.
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
- MRMC study: No. This is a surgical device, not a diagnostic or AI-assisted interpretation device. The concept of human readers improving with or without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. This device is a surgical tool, which by its nature is used with a human in the loop (a surgeon). There is no "algorithm only" performance to evaluate in this context.
7. The type of ground truth used
- Type of ground truth: Based on the "pre-clinical and tissue studies" mentioned, the ground truth would have been established through direct observation of the surgical effect on tissue, potentially including histopathology or other laboratory analyses to assess cutting, coagulation, vaporization effectiveness, and damage to surrounding tissue.
8. The sample size for the training set
- Sample size: Not applicable. This device is not an AI/ML device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable. As it's not an AI/ML device, there is no training set or associated ground truth establishment process.
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i21977
PLASMA SURGICAL
510(k) Summary
for the Plasma Surgical PlasmaJet® System (Version 3-Plus)
NOV 2 0 200
November 19th 2012
1 Submitter
Plasma Surgical Ltd 127 Milton Park Abingdon Oxfordshire OX14 4SA United Kingdom
| Contact Person: | Peter F Gibson |
|---|---|
| Telephone: | +44 1235 822506 |
| Facsimile: | +44 1235 820832 |
| E-mail: | pgibson@plasmasurgical.com |
2 Name of Device
Proprietary Name: PlasmaJet® system, comprising:
- a) PlasmaJet® console (Version 3-Plus)
- b) PlasmaJet® service module
- PlasmaJet® open surgery handpieces C)
- PlasmaJet® laparoscopic surgery handpieces d)
Neutral Plasma Surgery system Common Name:
Device Classification: Electrosurgical cutting and coagulation devices have been placed in Class II as per 21 CFR Regulation Number 878.4400 and assigned the Product Code GEI.
3 Predicate Devices
The components of the PlasmaJet® system are substantially equivalent to the following legally marketed devices: .
- K080197 Plasma Surgical PlasmaJet® Neutral Plasma Surgery System K031085 Gyrus PlasmaKinetic Superpulse Generator System & Accessories K100415 Lumenis AcuPulse 30/40ST and 40WG CO2 Laser Systems
Plasma Surgical Limited 127 Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom Telephone: +44 (0)1235 822500 Facsimile: +44 (0)1235 820832 Registered in England No. 3709815
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Intended Use ব
The PlasmaJet® system is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery.
Comparison to Predicate Devices ട്
The PlasmaJet® system that is the subject of this submission is identical in technological characteristics to the predicate PlasmaJet® device (K080197). The new handpieces with optimized performance for the subject PlasmaJet® system are similar in design, materials and construction to the handpieces of the predicate PlasmaJet® device and employ the same plasma energy source. They differ only in the internal dimensions of the electrode group to provide a more fine plasma stream and that is optimised for most effective use with rapidly pulsed plasma. The latest version of the PlasmaJet® console (Version 3-Plus) features rapidly pulsed plasma in a so-called "Ultra" mode that provides optimal cutting and coagulation capability. A user selectable pulse mode was present in the predicate PlasmaJet® device.
In its ability to cut and remove tissue, the action of the PlasmaJet® system is similar to that of the predicate Gyrus PlasmaKinetic Superpulse electrosurgery system (K031085) and the Lumenis AcuPulse CO2 laser (K100415). However, the energy of the plasma stream from the PlasmaJet® falls rapidly with distance and allows the surgeon to control the surgical effect by adjusting the distance to tissue.
e Summary of Substantial Equivalence
Pre-clinical and tissue studies have been performed and these have established that the PlasmaJet® neutral plasma surgery system provides safe and effective cutting, coagulation and removal of soft tissue by vaporization equivalent to predicate devices with minimal damage to underlying tissue.
Plasma Surgical Limited 127 Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom Telephone: +44 (0)1235 822500 Facsimile: +44 (0)1235 820832 Registered in England No. 3709815
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Plasma Surgical Limited % Dr. Peter Gibson Senior Vice-President 127 Milton Park . Abingdon, Oxfordshire United Kingdom OX14-4SA
November 20, 2012
Re: K121977
Trade/Device Name: PlasmaJet® Neutral Plasma Surgery System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 13, 2012 Received: November 14, 2012
Dear Dr. Gibson:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Dr. Peter Gibson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if Known): K121977
Device Name:
PlasmaJet® System
Indications for Use:
The PlasmaJet is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery.
Prescription Use X (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)
Division of Surgical Devices
K121977
Peter D. Rumm -S
Page 1 of 1
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Indications for Use
510(k) Number (if Known):
Device Name:
Indications for Use:
PlasmaJet® System
The PlasmaJet is a neutral plasma surgery system that is designed for cutting, coagulation and the removal of soft tissue by vaporization in open surgery and laparoscopic surgery.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFGR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Sungical Device 510(k) Ivuinto
Page 1 of
§ 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.