(10 days)
The VAPR 3 Electrosurgical System, when used with a VAPR Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.
The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.
VAPR 3 Electrosurgical System is designed to provide soft tissue ablation (vaporization), contouring, cutting and hemostasis of blood vessels during arthroscopic surgical procedures. The components of the system include a generator, handpiece and cable, electrodes, and footswitch.
The VAPR LD and LP Suction Electrodes are soft tissue ablation and dessication devices intended for use with the VAPR System. They extend the utility of the system by removing bubbles created during activation from the operating site.
The provided text details the 510(k) summary for the VAPR 3 Electrosurgical System and associated electrodes. It focuses on establishing substantial equivalence to predicate devices rather than presenting specific acceptance criteria and detailed study performance as would be expected for a novel AI/software medical device.
Therefore, many of the requested information points, particularly those related to AI/software performance metrics, ground truth establishment, expert review, and training/test set details, are not applicable or available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen for AI/software devices. Instead, it relies on demonstrating substantial equivalence to predicate devices through design control compliance, risk analysis procedures, and validation testing.
| Acceptance Criteria (Inferred from 510(k) Summary) | Reported Device Performance (Summary) |
|---|---|
| Compliance with 21 CFR 820.30 Design Control requirements | Certification of compliance provided. |
| Compliance with Mitek's subcontractor Design Control procedures | Descriptions of procedures provided. |
| Compliance with Mitek's Risk Analysis procedures | Descriptions of procedures provided. |
| Safety and Performance for intended use (tissue ablation, contouring, cutting, hemostasis) | Results of validation testing (performance testing) for the device modification submitted. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified. The document mentions "validation testing (performance testing) for the device modification" but does not provide details on the number of samples, cases, or procedures used in this testing.
- Data provenance: Not specified. It's highly likely that the testing involved in-house laboratory or simulated environments, given the nature of an electrosurgical system, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. For an electrosurgical device, performance is typically assessed through engineering tests, ex-vivo tissue studies, and potentially animal models or clinical studies (though a full clinical trial is often not required for 510(k) clearance if substantial equivalence can be shown). There is no mention of human experts establishing "ground truth" in the context of image interpretation or diagnostic accuracy.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. This concept is relevant for AI/software devices where expert consensus is needed to resolve discrepancies in annotations or diagnoses.
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 type of study is specific to diagnostic AI/software devices that assist human interpretation.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone study: Not applicable. The VAPR 3 Electrosurgical System is a hardware device operated by a surgeon. Its performance is inherent to its design and function, not an algorithm operating independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: Not explicitly stated in terms of a "ground truth" definition as used in AI/software evaluation. For an electrosurgical system, "ground truth" would relate to the physical effects on tissue (e.g., coagulation depth, ablation speed, safety of hemostasis, tissue temperatures), typically assessed through direct measurement, histological analysis of treated tissue (ex-vivo or in-vivo animal models), and functional performance tests against specified engineering criteria.
8. The sample size for the training set:
- Sample size for training set: Not applicable. This device is not an AI/machine learning product that requires training data in the conventional sense. Its "design" and "validation" involve engineering principles, materials science, and physical testing.
9. How the ground truth for the training set was established:
- Ground truth establishment for training set: Not applicable.
{0}------------------------------------------------
MAY 1 0 2004
510(k) Summary
Page 1 of 2
VAPR 3 Electrosurgical System and VAPR LD SUCTION and LP SUCTION Electrodes
KO 41135
| Submitter's Name andAddress: | DePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062 |
|---|---|
| Contact Person | Ruth C. ForstadtProject Management Lead, Regulatory AffairsDePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-3188Facsimile: 781-278-9578e-mail: rcforstad@ethus.jnj.com |
| Name of Medical Device | Classification Name: Electrosurgical cutting and coagulating deviceand accessoriesCommon/Usual Name: Electrosurgical System and ElectrodesProprietary Name: VAPR 3 Electrosurgical System, VAPR LDSUCTION and LP SUCTION Electrodes |
| Substantial Equivalence | VAPR 3 Electrosurgical System is substantially equivalent to theVAPRII Electrosurgical System (K002402, 8/31/2000).The VAPR LD Suction Electrode is substantially equivalent to theVAPR 2.3 Side Effect Electrode (K992876, 9/24/1999) and the VAPR3.5 Suction Electrode (K002422, 8/31/2000)The VAPR LP Suction Electrode is substantially equivalent to theVAPR LD Suction Electrode, a modification to the VAPR 2.3 SideEffect Electrode (K992876, 9/24/1999) and the VAPR 3.5 SuctionElectrode (K002422, 8/31/2000). |
| Device Classification | Electrosurgical cutting and coagulating device and accessories havebeen classified as Class II, GEI (21 CFR 878.4400). |
| Device Description | VAPR 3 Electrosurgical System is designed to provide soft tissueablation (vaporization), contouring, cutting and hemostasis of blood |
{1}------------------------------------------------
Page 2 of 2
vessels during arthroscopic surgical procedures. The components of the system include a generator, handpiece and cable, electrodes, and footswitch.
The VAPR LD and LP Suction Electrodes are soft tissue ablation and dessication devices intended for use with the VAPR System. They extend the utility of the system by removing bubbles created during activation from the operating site.
The VAPR 3 Electrosurgical System, when used with a VAPR Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.
The VAPR LD SUCTION and LP SUCTION Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.
In support of the 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification.
Based on the Indications for Use, technological characteristics and safety and performance testing, the VAPR 3 Electrosurgical System and VAPR LD and LP Suction Electrodes have been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
Indications for Use
Safety and Performance
ecial 510(k) /APR 3, LD and LP Suction Electrodes 70
CONFIDENTIAL
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. 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 a bird or other winged creature.
MAY 1 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mrs. Ruth C. Forstadt Project Management Lead, Regulatory Affairs DePuy Mitek 249 Vanderbilt Avenue Norwood, Massachusetts 02062
Re: K041135
Trade/Device Name: VAPR 3 Electrosurgical System Regulation Number: 21 CFR 878.4400, 21 CFR 888.1100 Regulation Name: Electrosurgical cutting and coagulation device and accessories Arthroscope Regulatory Class: II Product Code: GEI, HRX Dated: April 29, 2004 Received: April 30, 2004
Dear Ms Forstadt:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revea your your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease , 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, de needs marre neen rollated 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 r ou may, mererere, mains 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 may or subject to outsil 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 I hat FDA has made a determination that your device complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny i ederal station and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of K in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
Page 2 - Mrs. Ruth C. Forstadt
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letet notification. The FDA finding of substantial equivalence of your device to a legally premaince no licate 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
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): KO41135
VAPR 3 Electrosurgical System Device Name:_ VAPR LD and LP Suction Electrodes
Indications For Use:
The VAPR 3 Electrosurgical System, when used with a VAPR Electrode, is intended for The +AI It's Licettoourgious By of tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.
The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, The VAI K LD and EI- Cablation, excision of soft tissue, hemostasis of blood vessels and are intention of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.
Prescription Use x_
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
Page 1 of _
CONFIDENTIAL
ﻢ ﮐﮯ
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.