Reprocessed DePuy Mitek Ablation Wand

K173740 · Renovo, Inc. · NUJ · Mar 19, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173740
• Device Name: Reprocessed DePuy Mitek Ablation Wand
• Applicant: Renovo, Inc.
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: Mar 19, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Reprocessed radiofrequency (RF) surgical ablation wands; used for soft tissue resection, ablation, excision, hemostasis, and coagulation during arthroscopic procedures. Device consists of polycarbonate handle, stainless steel shaft, PET insulation, tungsten electrodes, alumina ceramic tip, and PVC suction line. Powered by external RF generator. Operated by surgeons in clinical/hospital settings. Reprocessing restores device to original OEM performance specifications. Output is thermal energy delivered to tissue via electrode tip. Benefits include effective tissue management during minimally invasive orthopedic surgery.

Clinical Evidence

No clinical data. Substantial equivalence is based on benchtop performance testing, including cleaning validation (residual protein/carbohydrates), functional testing (thermal effects, probe bending, probe drop), sterilization/packaging validation (EtO residuals, simulated shipment), shelf-life testing, and biocompatibility (cytotoxicity, irritation, acute systemic, pyrogenicity, sensitization).

Technological Characteristics

Materials: polycarbonate handle, stainless steel shaft, PET insulation, tungsten electrodes, alumina ceramic tip, PVC suction line. Energy source: external RF generator. Form factor: various diameters/lengths/electrode configurations. Sterilization: EtO. No software component.

Indications for Use

Indicated for patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow, and wrist for soft tissue resection, ablation, excision, hemostasis, and coagulation.

Regulatory Classification

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.

Predicate Devices

• VAPR Electrodes (K113545)
• VAPR Electrodes (K100638)
• VAPR P50 Electrode, VAPR S50 Electrode, VAPR S90 Electrode, VAPR P50 Electrode with handcontrols, VAPR S90 Electrode with Handcontrols (K122425)

Submission Summary (Full Text)

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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);

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K173740 Reprocessed DePuy Mitek Ablation Wands – Device Models Subject to Clearance

| OEM Model<br>Number | Name | Tip<br>Diameter | OEM 510(k) | Picture |
|---------------------|------------------------------|-----------------|--------------------|----------------------------------|
| 228146 | VAPR COOLPULSE 90 | 3.3mm | K113545<br>K100638 | Image: VAPR COOLPULSE 90 |
| 228147 | VAPR COOLPULSE 90<br>(w/ HC) | 3.3mm | K113545<br>K100638 | Image: VAPR COOLPULSE 90 (w/ HC) |
| 227204 | VAPR Premiere 90 | 3.3mm | K113545<br>K100638 | Image: VAPR Premiere 90 |
| 227504 | VAPR Premiere 50 | 3.0mm | K113545<br>K100638 | Image: VAPR Premiere 50 |
| 228504 | VAPR Premiere 50 (w/<br>HC) | 3.0mm | K113545<br>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 |

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# 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: [phone] Fax: [phone]

#### II. CONTACT PERSON

Mary Vater, BS, Regulatory Affairs Specialist Medical Device Academy 345 Lincoln Hill Rd. Shrewsbury, VT 05738 USA Tel: [phone] Email: [e-mail]

#### = 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

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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

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- 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.