ARTAS SYSTEM FROM RESTORATION ROBOTICS

K123154 · Restoration Robotics, Inc. · ONA · Feb 19, 2013 · Neurology

Device Facts

• Record ID: K123154
• Device Name: ARTAS SYSTEM FROM RESTORATION ROBOTICS
• Applicant: Restoration Robotics, Inc.
• Product Code: ONA · Neurology
• Decision Date: Feb 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The ARTAS" System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation.

Device Story

ARTAS System is an interactive, image-guided, computer-assisted stereotaxic instrument for hair transplantation. System components include a robotic arm, imaging subsystem, needle mechanism, safety subsystem, computer, patient chair, and accessory kits. Physician positions the system over the patient's scalp; imaging subsystem identifies follicular units; robotic arm automates the manual Follicular Unit Extraction (FUE) technique. System highlights follicles for harvest, tracks harvest progress, and automatically adjusts harvest direction based on fiducial markers on a skin tensioner. Output consists of extracted follicular units, which are manually implanted by a physician or technician. Device improves procedural efficiency and ease of use compared to manual methods. Used in clinical settings under physician direction.

Clinical Evidence

Clinical study conducted on 92 patients. Primary endpoints included efficacy (transection rates and non-implantable follicles) and safety. Study results confirmed that primary endpoints were met. Bench testing included software V&V, electrical safety (IEC-60601-1, IEC-60601-1-2), and biocompatibility testing.

Technological Characteristics

Stereotaxic instrument; robotic arm with image-guided needle mechanism. Connectivity: PC-based control cart. Sterilization: Gamma sterilization for disposable kits (ANSI/AAMI/ISO 11137 and 11737). Materials: Biocompatible patient-contacting components. Software: Computer-assisted image guidance with automated follicle identification and harvest path planning.

Indications for Use

Indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• ARTAS™ System (K103428)

Submission Summary (Full Text)

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510(k) PREMARKET NOTIFICATION

#### 510(k) Summary

## 510(k) Notification (K) K123154

GENERAL INFORMATION

Applicant:

Restoration Robotics, Inc. 128 Baytech Drive San Jose, CA 95134 U.S.A. Phone: [phone] FAX: [phone]

## Contact Person:

Jim Talbot Sr. Director Quality & Regulatory Affairs Restoration Robotics, Inc. 128 Baytech Drive San Jose, CA 95134 U.S.A. Phone: [phone] FAX: [phone]

Date Prepared: October 3, 2012

### DEVICE INFORMATION

The ARTASTM System from Restoration Robotics ("ARTAS™ System") is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTASTM System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation.

The ARTASTM System implements the manual Follicular Unit Extraction (FUE) approach to harvesting follicular units. The ARTASTM System is used, under the direction of a physician, to automate the manual FUE technique. The ARTAS™ System is positioned over the patient's scalp by the physician and follicular units are identified. Follicular units are then harvested from the patient's scalp. The follicular units are stored until they are implanted into the patient's scalp by the physician or technician using current manual implantation techniques.

#### Classification:

21CFR§882.4560, Stereotaxic Instrument

Product Code: ONA

Trade Name: The ARTAS™ System from Restoration Robotics

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## RESTORATION ROBOTICS, INC.

# SECTION 5 510(k) SUMMARY

## Generic/Common Name:

Stereotaxic Instrument

# PREDICATE DEVICES

The ARTASTM System is substantially equivalent to the following predicate device:

- ARTASTM System, K103428 .
## INDICATIONS FOR USE

The ARTAS" System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS" System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation.

## PRODUCT DESCRIPTION

The ARTASTM System implements the manual Follicular Unit Extraction (FUE) approach to harvesting follicular units. The ARTAS™ System is used, under the direction of a physician, to automate the manual FUE technique. The ARTAS™ System is positioned over the patient's scalp by the physician and follicular units are identified.

Follicular units are then harvested from the patient's scalp. The follicular units are stored until they are implanted into the patient's scalp by the physician or technician using current manual implantation techniques.

The ARTASTM System is an interactive, image-guided, computer-assisted system consisting of seven main subsystems;

- 1. Robotic Arm Subsystem
- 2. Imaging Subsystem
- 3. Needle Mechanism
- 4. Safety Subsystem
- 5. Computer
- 6. Accessory Kits (Disposable and Reusable)
- 7. Patient Chair

These main subsystems, with the exception of the Accessory Kits and Patient Chair, are housed on or within a Control Cart.

#### TECHNOLOGICAL CHARACTERISTICS

The predicate ARTASTM System provided left and right screen views on the monitor during the harvesting procedure. The left screen provided a view of the current follicle bcing harvested and the right screen a view of the next follicle selected for harvest. The present modified ARTASTM System provides a single, larger view of the follicle being harvested and a map view of the entire field of harvest.

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## SECTION 5 510(k) SUMMARY

The predicate ARTASTM System that was cleared by FDA in April 2011, (K103428) required harvesting parameters to be manually entered by the user by keying in numbers using a PC keyboard. The present system that is the basis of this submission incorporates toggle arrows for processing parameters on the computer monitor allowing a much simpler means by which to vary these parameters. This improvement in ease of use was validated clinically.

The modified ARTASTM System has been productized for cost reduction and manufacturability resulting in a system that is much more mobile than the predicate ARTASTM System. The improvements made in the system mobility along with the mechanism changes were validated clinically.

## Auto Hair Selection

The predicate ARTASTM System followed a harvesting process in which the system would move after completing a harvest and then highlight the next follicle for harvest. The present modified ARTASTM System highlights the next follicle for harvest while harvesting the initial follicle.

The predicate ARTASTM System required the user to adjust the direction of harvest for subsequent harvests once the needle completed a grid row. The present modified system recognizes the end of a row and changes direction automatically although, the user can still change the direction at any time. This change was made possible by incorporating fiducial markers on the skin tensioner that is applied to the patient scalp. This change improves the ease of use and was validated clinically.

#### Disposable Kit

Several changes in the disposables have been implemented in the present modiffed version of the ARTASTM System from the disposables included for the predicate system. The disposables used with the predicate ARTASTM System were provided non-sterile with instructions on how to sterilize the disposables using an autoclaye. The present disposable kit included with the modified ARTASTM System is provided gamma sterilized. This process has been validated in accordance with ANSI/AAMI/ISO 11137 and 11737 standards.

The change to provide the disposable kit sterile in the modified ARTASTM System submission requires that the present disposable kit bear a "Use By Date" that ensures sterility for a minimum of one (1) year. This shelf life was validated in accordance with ASTM F1980-07.

A design change was made to the punch used in the modified ARTASTM System resulting in a more reliable punch. This change was validated clinically.

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RESTOR ATION ROBOTICS, INC.

## SECTION 5 510(k) SUMMARY

#### NONCLINICAL TEST SUMMARY

Extensive testing was performed on the subject device to support a determination of substantial equivalence to the predicate device. This testing included software verification and validation, patient chair verification, system cart verification, and disposable and reusable verification. All required electrical safety tests including EMC (IEC-60601-1 and IEC60601-1-2) were also performed. Biocompatibility testing was performed on all patient contacting materials for the disposable and reusable components.

The testing referenced above includes all of the tests that were performed on the predicate device. Since the results were identical for these tests, substantial equivalence has been demonstrated through these nonclinical tests.

# CLINICAL TEST SUMMARY

A clinical study was performed on ninety-two (92) patients using the modified ARTASTM System. Primary efficacy (transection rates and non-implantable follicles) as well as safety endpoints were met.

#### SUBSTANTIAL EQUIVALENCE

The indications for use for the modified ARTASTM System is substantially equivalent to the indications for use of the predicate ARTAS™ System (K103428). Any differences in the technological characteristics between the devices do not raise any new issues of safety or efficacy. Thus, the modified ARTASTM System is substantially equivalent to the predicate device.

## TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary bench (mechanical, electrical, software performance, and biocompatibility testing) and clinical testing was conducted on the modified ARTAS™ System to support a determination of substantial equivalence to the predicate device.

#### SUMMARY

The modified ARTASTM System is substantially equivalent to the predicate device, ARTASTM System (K103428) cleared on April 4, 2011.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, with flowing lines representing support and care.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2013

Restoration Robotics, Incorporated % Mr. Jim Talbot Senior Director, Quality and Regulatory Affairs 128 Baytech Drive San Jose, California 95134

Re: K123154

Trade/Device Name: The ARTAS™ System from Restoration Robotics Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONA Dated: January 25, 2013 Received: February 01, 2013

Dear Mr. Talbot:

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 (2 1 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. Jim Talbot

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Peter D. Rumm -S

FOR

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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RESTORATION ROBOTICS, INC.

## THE ARTAS" SYSTEM FROM RESTORATION ROBOTICS 510(k) Premarket Notification

# SECTION 4 INDICATIONS FOR USE STATEMENT

K123154 510(k) Number (if known):

Device Name: The ARTAS™ System from Restoration Robotics

# Indications For Use:

The ARTAS" System from Restoration Robotics is indicated for harvesting hair follicles from the scalp in men diagnosed with androgenic alopecia (male pattern hair loss) who have black or brown straight hair. The ARTAS System from Restoration Robotics is intended to assist physicians in identifying and extracting hair follicular units from the scalp during hair transplantation.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/6/Picture/12 description: The image shows the name "Long H Chen -S" in large font on the left side of the image. On the right side of the image is a digital signature with the text "Digitally signed by Long H. Chen-S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Long H. Chen -S, 0.9.2342.19200300.100.1.1-130036 56 Date: 2013.02.19 14:42:17-05'00'". The digital signature is surrounded by a circular pattern.

(Division Sign-Off) Division of Surgical Devices 510 (k) Number: K123154