(10 days)
Not Found
No
The document describes a standard electrosurgical system and does not mention any AI or ML capabilities.
Yes
The device is used for resection, ablation, excision, hemostasis, and coagulation of soft tissues, which are all therapeutic procedures.
No
Explanation: The device is an electrosurgical system intended for therapeutic procedures such as resection, ablation, excision, and hemostasis of soft tissues, not for diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a generator, handpiece and cable, electrodes, and footswitch, 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 clearly describes a device used during surgical procedures (arthroscopic surgery) for direct intervention on soft tissues and blood vessels within the body. This is a therapeutic and surgical device, not a diagnostic one.
- Device Description: The description reinforces its function as an electrosurgical system for ablation, contouring, cutting, and hemostasis during surgery.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.) outside the body, which is a core characteristic of IVDs. The device is used directly on the patient's tissues.
IVDs are devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEI, HRX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, andle, elbow and wrist
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 and
Address: | DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ruth C. Forstadt
Project Management Lead, Regulatory Affairs
DePuy Mitek
a Johnson & Johnson company
249 Vanderbilt Avenue
Norwood, MA 02062
Telephone: 781-251-3188
Facsimile: 781-278-9578
e-mail: rcforstad@ethus.jnj.com |
| Name of Medical Device | Classification Name: Electrosurgical cutting and coagulating device
and accessories
Common/Usual Name: Electrosurgical System and Electrodes
Proprietary Name: VAPR 3 Electrosurgical System, VAPR LD
SUCTION and LP SUCTION Electrodes |
| Substantial Equivalence | VAPR 3 Electrosurgical System is substantially equivalent to theVAPR
II Electrosurgical System (K002402, 8/31/2000).
The VAPR LD Suction Electrode is substantially equivalent to the
VAPR 2.3 Side Effect Electrode (K992876, 9/24/1999) and the VAPR
3.5 Suction Electrode (K002422, 8/31/2000)
The VAPR LP Suction Electrode is substantially equivalent to the
VAPR LD Suction Electrode, a modification to the VAPR 2.3 Side
Effect Electrode (K992876, 9/24/1999) and the VAPR 3.5 Suction
Electrode (K002422, 8/31/2000). |
| Device Classification | Electrosurgical cutting and coagulating device and accessories have
been classified as Class II, GEI (21 CFR 878.4400). |
| Device Description | VAPR 3 Electrosurgical System is designed to provide soft tissue
ablation (vaporization), contouring, cutting and hemostasis of blood |
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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
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