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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed DePuy Mitek Ablation Wand. It does not contain information about an AI/machine learning device, nor does it provide the detailed specifics about acceptance criteria involving performance metrics like accuracy, sensitivity, or specificity, or the methodology for a multi-reader multi-case (MRMC) study.

The document discusses the substantial equivalence of the reprocessed device to its original (OEM) predicate devices based on various performance tests conducted to ensure that the reprocessing activities did not affect the form or function of the device and that it performs as well as the original, new device.

Therefore, many of the requested details about acceptance criteria and study methodology for an AI/ML device, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.

However, I can extract the acceptance criteria and performance data for this reprocessed medical device as presented in the document:

Acceptance Criteria and Device Performance for Reprocessed DePuy Mitek Ablation Wand

The acceptance criteria are implicitly defined by demonstrating that the reprocessed device performs equivalently to the original, new device in various tests. The study's goal was to prove substantial equivalence, meaning the reprocessed device is as safe and effective as the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Performance Acceptance (Implicit)	Reported Device Performance
Cleaning	Residual Protein and Carbohydrates	Levels below acceptable limits.	Testing performed; no specific levels reported, but deemed acceptable for clearance.
	Visual Inspection	No visible residue remaining.	Testing performed; no specific findings reported, but deemed acceptable for clearance.
	Cleaning Performance Qualification	Demonstrated effective cleaning.	Testing performed; no specific findings reported, but deemed acceptable for clearance.
Functional	Thermal Effects Performance Testing	Equivalent thermal performance to predicate device.	Performed; "The subject device performed equivalent to the predicate."
	Probe Bending Performance Testing	Equivalent bending resistance/performance to predicate device.	Performed; "The subject device performed equivalent to the predicate."
	Probe Drop Performance Testing	Equivalent durability/performance after drop to predicate device.	Performed; "The subject device performed equivalent to the predicate."
Sterilization and Packaging	EtO Sterilization Testing	Sterility assurance level (SAL) achieved.	Testing performed; deemed acceptable.
	EtO Residuals Testing	Ethylene Oxide (EtO) residuals below acceptable limits.	Testing performed; deemed acceptable.
	Simulated Shipment Testing	Device integrity and functionality maintained after simulated shipment.	Testing performed; deemed acceptable.
Product Stability	Shelf Life Testing (1-year Accelerated Aging)	Maintains safety and effectiveness after 1 year accelerated aging.	Testing performed; deemed acceptable.
	Real-Time Shelf Life studies	On-going to confirm long-term stability beyond accelerated aging.	"on-going and are not complete for inclusion in this submission. "
Biocompatibility	Cytotoxicity	Non-cytotoxic.	Testing performed; deemed acceptable.
	Irritation	Non-irritating.	Testing performed; deemed acceptable.
	Acute Systemic Toxicity	No acute systemic toxic effects.	Testing performed; deemed acceptable.
	Material Mediated Pyrogenicity	Non-pyrogenic.	Testing performed; deemed acceptable.
	Sensitization	Non-sensitizing.	Testing performed; deemed acceptable.
Electrical Safety / EMC	IEC 60601-1-2 EMC Testing	Meets electromagnetic compatibility standards.	Testing performed; deemed acceptable.
	IEC 60601-2-2 Electrical Safety Testing	Meets electrical safety standards for high-frequency equipment.	Testing performed; deemed acceptable.
Software Verification and Validation	Software Testing	N/A (Device does not contain software).	"Software Testing is not applicable, because the device does not contain software."
Mechanical and Acoustic Testing	Mechanical and Acoustic Performance Testing	N/A (Not required to demonstrate safety/effectiveness for this device).	"Mechanical and acoustic performance testing was not required to demonstrate safety and effectiveness of the device."
Animal Study	Animal Performance Testing	N/A (Not required to demonstrate safety/effectiveness for this device).	"Animal performance testing was not required to demonstrate safety and effectiveness of the device."
Clinical Studies	Clinical Testing	N/A (Benchtop performance testing sufficient for substantial equivalence).	"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."

2. Sample size used for the test set and the data provenance

The document indicates "side by side" testing with predicate devices. Specific sample sizes for each test are not provided. The data provenance is presumed to be from the manufacturer's internal testing facilities, as is typical for 510(k) submissions, but a specific country of origin for the data generation or whether it was retrospective/prospective is not mentioned. Given the nature of benchtop testing, it would be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "ground truth" for this reprocessed device relates to its physical, functional, and electrical performance compared to a new, predicate device, not to diagnostic interpretation requiring expert consensus. Performance is measured against engineering specifications and industry standards.

4. Adjudication method for the test set

Not applicable. Performance testing for this device does not involve human interpretation requiring adjudication.

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

Not applicable. This is a reprocessed medical device, not an AI/machine learning diagnostic aid.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm. Its performance is measured directly through benchtop tests.

7. The type of ground truth used

The "ground truth" for this device is based on engineering specifications, established performance standards, and comparison to the performance of the new, predicate device. For cleaning, it refers to the absence of residues. For functional performance, it's the measured performance (e.g., thermal effects, bending, drop) being equivalent to the predicate. For biocompatibility, it's meeting ISO standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K173740

Device Name

Reprocessed DePuy Mitek Ablation Wand

Indications for Use (Describe)

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

OEM ModelNumber	Name	TipDiameter	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

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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: +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

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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.

Regulation Number and Section

§ 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.