THE ARTAS SYSTEM FROM RESTORATION ROBOTICS

K103428 · Restoration Robotics, Inc. · ONA · Apr 4, 2011 · Neurology

Device Facts

• Record ID: K103428
• Device Name: THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
• Applicant: Restoration Robotics, Inc.
• Product Code: ONA · Neurology
• Decision Date: Apr 4, 2011
• 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 automates manual Follicular Unit Extraction (FUE) for hair transplantation. Physician positions robotic arm over patient scalp; imaging subsystem identifies follicular units; needle mechanism dissects and extracts units from surrounding tissue. Extracted units transported via suction to storage container for manual implantation by physician/technician. System comprises robotic arm, imaging, needle mechanism, safety subsystem, computer, accessory kits, and patient chair; housed on control cart. Used in clinical setting under physician direction. Benefits include automated, consistent follicular unit harvesting compared to manual techniques.

Clinical Evidence

Multi-center, prospective, blinded clinical study (n=36) comparing ARTAS-harvested vs. manual-harvested hair follicles in men (ages 30-59) with androgenetic alopecia. Primary endpoint: survival of implanted follicles at 9 months. Results showed ARTAS equivalent to manual method (p=0.023). No serious adverse events reported; all complications mild.

Technological Characteristics

Stereotaxic instrument; image-guided robotic system. Components: robotic arm, imaging subsystem, needle mechanism, safety subsystem, computer, accessory kits, patient chair. Software-controlled automation of manual FUE. Bench testing included electrical safety, EMC, software V&V, hardware verification, and cytotoxicity.

Indications for Use

Indicated for men aged 30-59 with androgenetic alopecia (male pattern hair loss) and 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

• Medicamat S.A. Calvitron Hair Transplant System (K952737)
• Integrated Surgical Systems, Inc. DigiMatch ROBODOC Surgical System (K072629)

Submission Summary (Full Text)

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#### THE ARTAS™ SYSTEM FROM RESTORATION ROBOTICS 510(k) PREMARKET NOTIFICATION

# SECTION 5

510(K) SUMMARY (CONT.)

Pg. 1 of 4

#### 510(k) Notification K103428

GENERAL INFORMATION

Applicant:

Restoration Robotics, Inc. 1383 Shorebird Way Mountain View, CA 94043 U.S.A. Phone: [phone] FAX: [phone]

# Contact Person:

Kit Cariquitan Vice President, Regulatory Affairs Experien Group, LLC 155-A Moffett Park Drive, Suite 210 Sunnyvale, CA 94089 U.S.A. Phone: [phone] FAX: [phone]

Date Prepared: November 19, 2010

#### DEVICE INFORMATION

# Classification:

21CFR §882.4560, Stereotaxic Instrument

Product Code:

ONA

Trade Name: The ARTAS™ System

Generic/Common Name: Stereotaxic Instrument

#### PREDICATE DEVICES

The ARTAS System is substantially equivalent to the following predicate devices:

- Medicamat S.A. Calvitron Hair Transplant System, K952737 .
- Integrated Surgical Systems, Inc. DigiMatch ROBODOC Surgical System, . K072629

APR - 4 2011

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# SECTION 5 510(K) SUMMARY (CONT.)

K103428

### INTENDED 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 ARTAS 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. Follicular units are then identified, dissected and extracted from the surrounding tissue on the patient's scalp by the ARTAS System. The follicular units are transported using suction to a storage container where they are stored until they are implanted into the patient's scalp by the physician or technician using current manual implantation techniques.

The ARTAS 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.

#### SUBSTANTIAL EQUIVALENCE

The proposed indications for use for the ARTAS System is substantially equivalent to the indications for use of the Medicamat S.A. Calvitron Hair Transplant System. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the ARTAS System is substantially equivalent to the predicate devices.

#### TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

All necessary functional and clinical testing was conducted on the ARTAS System to support a determination of substantial equivalence to the predicate devices.

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| SECTION 5 |
|------------------------|
| 510(K) SUMMARY (CONT.) |

#### Nonclinical Testing Summary:

The nonclinical, bench testing included:

- Electrical Safety and Electromagnetic Compatibility Testing .
- Software Verification and Validation Testing .
- Hardware Design Verification Testing .
- � Cytotoxicity Testing

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the ARTAS System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the ARTAS System does not raise new questions of safety or effectiveness for follicular unit extraction when compared to the manual procedure.

## Clinical Testing Summary:

A multi-center, prospective, blinded, clinical study was performed to compare the safety and effectiveness of the ARTAS System to the manual hair follicle harvesting method following a nine month period of post-procedural evaluation. The clinical study enrolled healthy men, between the ages of 30 and 59, who had brown or black straight hair and a clinical diagnosis of androgenetic alopecia (male pattern hair loss).

A total of 36 subjects were treated in this study at two U.S. clinical sites. The mean age of the participants was 48.6 ± 7.5. Subjects predominantly had black hair and stage V or VI baldness on the Norwood-Hamilton Classification scale. The population at both sites was similar.

There were no adverse events, serious adverse events or unanticipated adverse events reported by any subjects during the course of this study. All complications were "Mild" in intensity. None of the subjects terminated the study early due to any safety-related issues.

The primary effectiveness endpoint was the difference in the number of surviving implanted hair follicles at Month 9 post-implantation between those implanted hair follicles that were harvested using the ARTAS System and those that were harvested using the manual method of hair harvest. In comparing the implant results by hair follicle harvest method, the ARTAS System was found to be substantially equivalent to the manual harvest method at nine months (p = 0.023). The primary effectiveness endpoint of this study was achieved.

Page 384

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· THE ARTAS™ SYSTEM FROM RESTORATION ROBOTICS 510(k) PREMARKET NOTIFICATION

# SECTION 5 510(K) SUMMARY (CONT.)

K103428

Page 4 of 4

# CONCLUSION

As demonstrated in this clinical study, no new issues of safety or effectiveness are raised by implementing computer-assisted techniques for follicular unit extraction as compared to the manual procedure. The nonclinical and clinical testing of the ARTAS System has demonstrated the device to be at least as safe and effective as the legally marketed predicate devices.

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Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HS" are arranged in a semi-circular fashion around the bird symbol.

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

Restoration Robotics, Inc. % Experien Group, LLC Kit Cariquitan Vice President, Regulatory Affairs 155-A Moffett Park Drive, Suite 210 Sunnyvale, California 94089

APR - 4 2011

Re: K103428

Trade/Device Name: The ARTAS™ System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: ONA Dated: March 21, 2011 Received: March 22, 2011

### Dear Kit Cariquitan:

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.

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Page 2 - Kit Cariquitan

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); 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/AboutlFDA/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/default.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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

ereby yours,

F-e A.V. Def D.A

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2103428

# SECTION 4

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K103428

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)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nihil for maken
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103428