(102 days)
No reference devices were used in this submission.
No
The document describes a radiofrequency surgical device and its reprocessing, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as being used for "resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues," which are all therapeutic actions.
No
Explanation: The device is described as a surgical tool for resection, ablation, excision, hemostasis, and coagulation of soft tissues, not for diagnosing conditions.
No
The device description explicitly details physical components (handles, shafts, insulation, electrodes, tips, suction lines) and the performance studies include testing on these physical attributes (bending, drop, electrical safety, biocompatibility). The "Software Verification and Validation Testing: Not applicable" further confirms 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 states the device is for "resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a "radiofrequency surgical device" used in "arthroscopic and orthopedic procedures." This further reinforces its use in surgical interventions.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The provided information does not mention any analysis of specimens or diagnostic purposes.
Therefore, the Reprocessed DePuy Mitek Ablation Wands are surgical devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The Reprocessed DePuy Mitek Ablation Wands for use with the VAPR Electrosurgical System are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
Product codes
NUJ
Device Description
Reprocessed DePuy Mitek Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, hip, ankle, 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
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing
- Cleaning
- Residual Protein and Carbohydrates O
- O Visual Inspection
- Cleaning Performance Qualification O
- Functional
- Thermal Effects Performance Testing o
- Probe Bending Performance Testing O
- Probe Drop Performance Testing O
- Sterilization and Packaging
- EtO Sterilization Testing O
- EtO Residuals Testing O
- Simulated Shipment Testing o
- Product Stability
- Shelf Life Testing 1-year Accelerated Aging O
- Real-Time Shelf Life studies are on-going and are not complete for inclusion in this O submission.
Biocompatibility Testing
The following biocompatibility tests were conducted to ensure the safety of the devices:
- Cytotoxicity
- Irritation
- Acute Systemic
- Material Mediated Pyrogenicity
- Sensitization
Electrical safety and electromagnetic compatibility (EMC)
The following electrical safety and EMC tests have been performed:
- IEC 60601-1-2 EMC Testing
- IEC 60601-2-2 Electrical Safety Testing (high frequency equipment/accessories) .
Software Verification and Validation Testing
Software Testing is not applicable, because the device does not contain software.
Mechanical and acoustic Testing
Mechanical and acoustic performance testing was not required to demonstrate safety and effectiveness of the device.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the Reprocessed DePuy Mitek Ablation Wand. Instead, substantial equivalence is based upon benchtop performance testing.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
March 19, 2018
ReNovo. Inc. % Mr. Robert Packard Medical Device Academy, Inc. 345 Lincoln Hill Rd. Shrewsbury, Vermont 05738
Re: K173740
Trade/Device Name: Reprocessed DePuy Mitek Ablation Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: NUJ Dated: February 14, 2018 Received: February 15, 2018
Dear Mr. Packard:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173740
Device Name
Reprocessed DePuy Mitek Ablation Wand
Indications for Use (Describe)
The Reprocessed DePuy Mitek Ablation Wands for use with the VAPR Electrosurgical System are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K173740 Reprocessed DePuy Mitek Ablation Wands – Device Models Subject to Clearance
| OEM Model
Number | Name | Tip
Diameter | OEM 510(k) | Picture |
|---------------------|------------------------------|-----------------|--------------------|----------------------------------|
| 228146 | VAPR COOLPULSE 90 | 3.3mm | K113545
K100638 | Image: VAPR COOLPULSE 90 |
| 228147 | VAPR COOLPULSE 90
(w/ HC) | 3.3mm | K113545
K100638 | Image: VAPR COOLPULSE 90 (w/ HC) |
| 227204 | VAPR Premiere 90 | 3.3mm | K113545
K100638 | Image: VAPR Premiere 90 |
| 227504 | VAPR Premiere 50 | 3.0mm | K113545
K100638 | Image: VAPR Premiere 50 |
| 228504 | VAPR Premiere 50 (w/
HC) | 3.0mm | K113545
K100638 | Image: VAPR Premiere 50 (w/ HC) |
| 225370 | VAPR S90 | 4.0mm | K122425 | Image: VAPR S90 |
| 228370 | VAPR S90 (w/ HC) | 4.0mm | K122425 | Image: VAPR S90 (w/ HC) |
| 225361 | LPS (2-Piece Electrode) | 4.0mm | K113545 | Image: LPS (2-Piece Electrode) |
| 225360 | LDS (2-Piece Electrode) | 4.0mm | K113545 | Image: LDS (2-Piece Electrode) |
| 227355 | VAPR S50 | 3.0mm | K122425 | Image: VAPR S50 |
4
K173740 - 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
1. SUBMITTER
ReNovo, Inc. Mark K. Wells 340 SW Columbia St. Bend OR, 97702 USA Tel: +1.541.422.8880 Fax: +1.541.422.8881
II. CONTACT PERSON
Mary Vater, BS, Regulatory Affairs Specialist Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, VT 05738 USA Tel: +1.913.274.9899 Email: mary@fdaecopy.com
= DEVICE
Name of Device: Classification Name: Regulation: Requiatory Class: Product Classification Code: NUJ
Reprocessed DePuy Mitek Ablation Wand Electrosurgical Cutting and Coagulation Device and Accessories 21 CFR §878.4400 Class II
IV. PREDICATE (OEM) DEVICES
Predicate Manufacturer: DePuy Mitek Predicate Trade Name: VAPR Electrodes Predicate 510(k): K113545
Predicate Manufacturer: DePuy Mitek Predicate Trade Name: VAPR Electrodes Predicate 510(k): K100638
Predicate Manufacturer: DePuy Mitek Predicate Trade Name: VAPR P50 Electrode, VAPR S50 Electrode, VAPR S90 Electrode, VAPR P50 Electrode with handcontrols, VAPR S90 Electrode with Handcontrols Predicate 510(k): K122425
No reference devices were used in this submission.
V. DEVICE DESCRIPTION
Reprocessed DePuy Mitek Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten
5
electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.
VI. INDICATIONS FOR USE
The Reprocessed DePuy Mitek Ablation Wands for use with the V APR Electrosurgical System are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVCE
The fundamental technological characteristics of the subject device are identical to the predicate. The subject devices are reprocessed versions of the predicate devices. Validation was done to ensure that the reprocessing activities did not affect the form or function of the device, and that the reprocessed device performs as well as the original, new device.
The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:
- . Indications for Use – The predicate and subject device have substantially equivalent intended uses. Both are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
- . Materials - The subject devices are identical reprocessed versions of the predicate OEM devices, therefore the subject devices materials are identical to the predicate.
- Design - The predicate and subject devices are identical in design changes are made during reprocessing.
- . Energy Source - The predicate and subject devices are both powered by external RF Generators.
- . Performance Testing - The subject devices were tested side by side with predicate devices for thermal effects, probe bending, and probe drop performance. The subject device performed equivalent to the predicate
VIII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Performance Testing
- · Cleaning
- Residual Protein and Carbohydrates O
- O Visual Inspection
- Cleaning Performance Qualification O
- · Functional
- Thermal Effects Performance Testing o
- Probe Bending Performance Testing O
- Probe Drop Performance Testing O
- · Sterilization and Packaging
- EtO Sterilization Testing O
- EtO Residuals Testing O
6
- Simulated Shipment Testing o
- Product Stability
- Shelf Life Testing 1-year Accelerated Aging O
- Real-Time Shelf Life studies are on-going and are not complete for inclusion in this O submission.
Biocompatibility Testing
The following biocompatibility tests were conducted to ensure the safety of the devices:
- · Cytotoxicity
- · Irritation
- · Acute Systemic
- · Material Mediated Pyrogenicity
- · Sensitization
Electrical safety and electromagnetic compatibility (EMC)
The following electrical safety and EMC tests have been performed:
- . IEC 60601-1-2 EMC Testing
- IEC 60601-2-2 Electrical Safety Testing (high frequency equipment/accessories) .
Software Verification and Validation Testing
Software Testing is not applicable, because the device does not contain software.
Mechanical and acoustic Testing
Mechanical and acoustic performance testing was not required to demonstrate safety and effectiveness of the device.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Studies
Clinical testing was not required to demonstrate the safety and effectiveness of the Reprocessed DePuy Mitek Ablation Wand. Instead, substantial equivalence is based upon benchtop performance testing.
IX. CONCLUSIONS
Based on a comparison of technological characteristics, indications for use, and performance data, it can be concluded that the proposed Reprocessed DePuy Mitek Ablation Wand devices are substantially equivalent to the predicate (OEM) devices.