SMARTO

K163308 · Jeil Medical Corporation · KIJ · Dec 27, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K163308
• Device Name: SMARTO
• Applicant: Jeil Medical Corporation
• Product Code: KIJ · General, Plastic Surgery
• Decision Date: Dec 27, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

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

Device Story

SMARTO is a DC-powered, handheld surgical motor unit used for drilling and driving screws during orthopedic and reconstructive surgeries. The device consists of a motor, switch, and rotation attachment holder. It is supplied radiation-sterile for single-use. Operated by surgeons in clinical settings, the device provides mechanical rotational force to surgical attachments. The device is powered by AAA alkaline batteries. The healthcare provider manually controls the device via an integrated switch to perform bone drilling or screw fixation. The device facilitates surgical procedures by providing consistent torque and speed for hardware placement, potentially reducing operative time and improving precision in bone reconstruction.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against internal standards for torque and speed. Electrical safety verified per IEC 60601-1; electromagnetic compatibility verified per IEC 60601-1-2.

Technological Characteristics

DC-powered handheld surgical motor unit. Energy source: AAA alkaline batteries. Features mechanical lock, switch, and holder assembly. Sterilization: Radiation. Compliance: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC). Specifications include torque (up to 45Ncm) and speed (up to 250 RPM) variations based on model.

Indications for Use

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

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

• SMARTO (K101563)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 graphic of three human profiles facing to the right, stacked on top of each other.

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

December 27, 2016

Jeil Medical Corporation Mr. Jaehan Park RA Manager #702 Kolon Science Valley 2nd, 55, Digital-ro34, Guro-gu, Seoul, 152-728 South Korea

Re: K163308

Trade/Device Name: SMARTO Regulatory Class: Unclassified Product Code: KIJ Dated: November 17, 2016 Received: November 23, 2016

Dear Jaehan Park:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Jennifer R. Stevenson -A

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K163308

Device Name SMARTO

# Indications for Use (Describe)

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

| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|------------------------------------------------------------------------------------|-----------------------------------------------|
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K163308

Image /page/3/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION, followed by their address and contact information. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is [phone], and the fax number is [phone].

# 510(k) Summary

[As required by 21 CRF 807.92]

### 1. Date Prepared [21 CRF 807.92(a)]

22. November 2016

# 2. Submitter's Information

| • Name of Sponsor: | Jeil Medical Corporation |
|-------------------------|------------------------------------------------------------------------------------|
| - Address: | #702 Kolon Science Valley 2nd, 55, Digital-ro34, Guro-gu,<br>Seoul, 152-728, Korea |
| • Contact Name : | Seungyong Lee / RA Specialist |
| - Telephone No. : | [phone] |
| - Fax No. : | [phone] |
| - Email Address : | [e-mail] |
| • Registration Number : | 3004049923 |
| • Name of Manufacturer: | Same as Sponsor |
| - Address: | Same as Sponsor |

### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

| • Trade Name: | SMARTO |
|------------------|---------------------------------|
| • Common Name: | Surgical motor unit for surgery |
| • Product Code: | KIJ |
| • Device Class: | Unclassified |

# 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[

The identified predicate devices within this submission are shown as follow;

- 510(k) Number: K101563
- Applicant: Jeil Medical Corporation
- Common Name: Surgical motor unit for surgery
- Device Name: SMARTO

Surgical motor unit for surgery

There are no significant differences between the Additional models and the predicate devices(K101563)that would adversely affect the use of the product.

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# K163308

Image /page/4/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION, along with their address and contact information. The address is 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is [phone], and the fax number is [phone].

# 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow;

- 510(k) Number: K101563
- Applicant: Jeil Medical Corporation
- · Common Name: Surgical motor unit for surgery
- SMARTO • Device Name:

### 5. Description of the Device [21 CFR 807.92(a)(4)]

The SMARTO is an DC-powered device that includes a hand-held motor, switch and hold for the rotation attachment for surgery. It is supplied radiation-sterile and disposable use.

### 6. Intended Use [21 CFR 807.92(a)(5)]

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

### 7. Technological Characteristics [21 CFR 807.92(a)(6)]

SMARTO: With same indication and operational principle. But, dimension and specification changed some specifications of DC motor have increased for the effective use to indication under the predicate (unmodified) devices (K101563)

#### Non-Clinical Test Summary:

The test was conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards and worst case criteria report:

- Electrical Safety: IEC 60601-1
- Electromagnetic Compatibility: IEC 60601-1-2
- Performance Test Torque: Internal standard Speed (RPM): Internal standard

The subject device has the same device characteristics as the predicate( unmodified) device.

#### Summary of the changed specification:

| Part or spec. | Description of changes | Remark |
|-----------------|----------------------------------------------------------------------------|--------|
| Body of Product | Shape<br>Part of assemble with switch<br>Part of assemble with holder assy | |
| Switch Rubber | Shape<br>Round → Square | |
| | Dimension<br>$Ø$ 8.0 mm → width 12.5 mm | |

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Image /page/5/Picture/1 description: The image shows the logo for JEIL MEDICAL CORPORATION. Below the logo is the address: 702-703-704-705-706-804-805-807-812-ho, 55, Digital-ro34-gil, Guro-gu, 08378, Korea. The telephone number is [phone] and the fax number is [phone].

| Holder Assy | Shape | Part of assemble with mechanical lock |
|----------------------------------------|---------------------------|---------------------------------------|
| DC Motor | Torque | 24Ncm → 45Ncm |
| DC Motor | Speed (RPM) | 160 RPM → 210 RPM |
| PCB | PCB Pattern<br>Add Switch | |
| Mechanical Lock | Add new part & function | |
| Unit of Battery<br>(1.5V AAA Alkaline) | 111-ED-050 | 2.0ea → 4ea |
| | 111-ED-031, 051 | 2.0ea → 3ea |
| Performance<br>(Torque) | 111-ED-031 | 24Ncm → 30 Ncm |
| | 111-ED-050 | 24Ncm → 45 Ncm |
| | 111-ED-051 | 24Ncm → 40 Ncm |
| | 111-ED-052 | 24Ncm → 35 Ncm |
| Performance<br>(RPM) | 111-ED-031 | 160 RPM → 250 RPM |
| | 111-ED-050 | 160 RPM → 210 RPM |
| | 111-ED-051 | 160 RPM → 165 RPM |
| | 111-ED-052 | 160 RPM → 110 RPM |

### 8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

The subject device has the same device characteristics as the predicate (unmodified) device. They have the same intended use, materials, energy source, design & use concept and sterilization. The differences are technical specification (Torque, Motor speed) and supply power.

However the performance and safety test data provided in this submission prove that this differences do not raise new issues in safety and performance.

# 9. Conclusion [21 CFR 807.92(b)(3)]

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 SMARTO is safe and effective and substantially equivalent to the predicate (unmodified) device as described herein.