SMARTO

K101563 · Jeil Medical Corporation · KIJ · Dec 17, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K101563
• Device Name: SMARTO
• Applicant: Jeil Medical Corporation
• Product Code: KIJ · General, Plastic Surgery
• Decision Date: Dec 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The SMARTO is intended for use in driving screws, and drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.

Device Story

SMARTO is a sterile, disposable, battery-powered surgical screwdriver; includes DC motor, battery, switch, and rotation attachment holder. Used by surgeons in clinical settings for drilling and driving screws during craniofacial, craniotomy, and extremity reconstruction procedures. Device provides mechanical torque for bone fixation; single-use design eliminates reprocessing requirements; benefits include portability and sterility assurance for surgical staff.

Clinical Evidence

Bench testing only. Performance testing evaluated mechanical properties, specifically motor speed and torque, to demonstrate safety and effectiveness.

Technological Characteristics

Battery-powered DC motor; disposable; sterile; handheld form factor; includes rotation attachment holder and switch. No software or connectivity features.

Indications for Use

Indicated for patients undergoing craniofacial (excluding oromaxillofacial), craniotomy, hand, foot, wrist, and extremity reconstruction surgical procedures requiring screw driving or drilling.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• OSTEOMED "B" power system and accessories (K933101)

Submission Summary (Full Text)

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ATTACHMENT 1

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DEC 1 7 2018

# 702, Kolon Science Valley 2nd, 811

Guro-Dong, Guro-Gu, Seoul, 152-050 Korea
Tel: [phone] / Fax: [phone]

# 510(k) Summary

K101563

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

October 19, 2010 Date: Date:

1. Company and Correspondent making the submission:

| | Company |
|---------|-----------------------------------------------------------------------------------------------|
| Name | Jeil Medical Corporation |
| Address | #702, kolon science valley 2nd<br>811, Guro-Dong, Guro-Gu<br>Seoul, Republic of Korea 152-050 |
| Phone | [phone] |
| Fax | [phone] |
| Contact | Jieun Kim |

## 2. Device:

Proprietary Name - SMARTO Common Name - Surgical motor unit for surgery Classification Name -- Instrument, Surgical orthopedic, DC-powered motor and accessory/attachment

#### 3. Predicate Device:

The OSTEOMED "B" power system and accessories, K933101

- 4. Classifications Names & Citations: KIJ, Unclassified
## 5. Description:

The device includes a DC The SMARTO is a sterile battery powered screwdriver. motor, battery, switch and holder for the rotation attachment. It is disposable.

#### 6. Indication for use:

The SMARTO is used to drive screws, and drilling in conjunction with craniofacial (does not include maxillofacial applications), craniotomies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and is for single use only.

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Guro-Dona, Guro-Gu, Seoul, 152-05 Tel : [phone] / Fax : [phone]

7. Review:

The SMARTO is substantially equivalent to the commercially available predicate products based on the intended use, technology, energy source, claims, and the material composition employed. Accordingly we can claim the substantially equivalence of the SMARTO to predicate devices.

- 8. Summary of performance testing:
Bench testing has been performed on mechanical properties; motor speed, torque. The results of Bench test show the safety and effectiveness of the SMARTO.

- 9. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Jeil Medical Corporation concludes that the SMARTO are safe and effective and substantially equivalent to predicate devices as described herein.

END

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The logo is black and white.

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

DEC 1 7 2010

Jeil Medical Corporation % GS Standard Co., Ltd. Kim Seong Nam 1006 Digital 2 Cha Valley Byucksan, Gasan-Seoul Republic of Korea

Re: K101563

Trade/Device Name: SMARTO Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachment Regulatory Class: Class I Product Code: KIJ Dated: December 05, 2010 Received: December 08, 2010

Dear Kim Seong Nam:

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 - Kim Seong Nam

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 (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/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/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 yours,

Sincerely yours,

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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# ATTACHMENT 3

510(k) Submission - SMARTO

510(k) Number K101563

Device Name: SMARTO

Indication for use:

The SMARTO is intended for use in driving screws, and drilling in conjunction with craniofacial (does not include oromaxillofacial applications), craniotomies, hand, foot, wrist and extremity reconstruction surgical procedures. It is supplied sterile and single use only.

OR Over-The-Counter Use Prescription Use (Per 21CFR807 Subpart C) (Per 21CFR801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogden for mxm

ical, Orthopedic, tive Devices

510(k) Number K101563