Cocoon Portable Handheld X-Ray System

K173046 · Dexcowin Co., Ltd. · MUH · Oct 26, 2017 · Dental

Device Facts

• Record ID: K173046
• Device Name: Cocoon Portable Handheld X-Ray System
• Applicant: Dexcowin Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Oct 26, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.1800
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Cocoon device is intended for use in dental radiographic examination and diagnosis of the teeth, jaw, and oral structure for both pediatric and adult patients.

Device Story

Cocoon is a handheld, portable dental X-ray system; utilizes internal X-ray tube to expose intraoral receptors (analog film, digital phosphorous plates, or digital sensors) to ionizing radiation. Operated by dental professionals in clinical settings; handheld or tripod-mounted. Device transforms electrical energy from a 16.8V DC Li-Polymer battery into controlled X-ray pulses (70kVp; 1.7mA or 2.0mA). Exposure parameters (0.05–1.00s) set by operator; output used for diagnostic imaging of teeth, jaw, and oral structures. Benefits include portability for dental radiographic examinations. Clinical decision-making supported by resulting images.

Clinical Evidence

Bench testing only. Performance validated through electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), radiation protection (IEC 60601-1-3), usability (IEC 60601-1-6, IEC 62366-1), and dental-specific safety (IEC 60601-2-65). No clinical data provided.

Technological Characteristics

Handheld X-ray system; 16.8V DC Li-Polymer battery powered. Tube voltage 70kVp (fixed); tube current 1.7mA (DX-7017) or 2.0mA (DX-7020). Dimensions: 7.6"x5.2"x10.6"; weight 5.0 lbs. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-65, ISO 10993-1, ISO 14971. Software lifecycle per IEC 62304.

Indications for Use

Indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or digital sensors.

Regulatory Classification

Identification

An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.

Predicate Devices

• DX-3000 Portable X-ray System (K133007)

Reference Devices

• ADX4000-L (K083532)
• DX3000-L (K083532)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.

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

October 26, 2017

Dexcowin Co., Ltd. % Ms. Joyce St. Germain Regulatory Department Manager 100 East Granada Blvd., Suite 219 ORMOND BEACH FL 32176

Re: K173046

Trade/Device Name: Cocoon Portable Handheld X-ray System Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: September 26, 2017 Received: September 28, 2017

Dear Ms. St. Germain:

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 (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.

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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/Resourcesfor You/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 yours.

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K173046

## Device Name

Cocoon Portable Handheld X-ray system

Indications for Use (Describe)

Cocoon is a portable X-ray System indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or digital sensors.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows a stylized drawing of an eagle's head and wing. The eagle's head is facing to the right, and its beak is slightly open. The wing is spread out behind the head, and it has five feathers. The drawing is done in black and white, and the lines are clean and simple.

510k FDA Consulting

Medical Device Clearance

100 East Granada Blvd., Suite 219

Ormond Beach, FL 32176

386-506-8711

# Special 510(k) Summary / K173046

#### Submitter/Applicant

Dexcowin Co., Ltd. #905, 2, Gasan digital 1-ro, GeumCheon-Gu Seoul, Korea 08591

| Phone: | 82-2-2027-2880 |
|----------|-------------------------------------------------|
| Fax: | 82-2-2027-2884 |
| Contact: | Ryu Seung-Bum ([e-mail])Date Prepared |

September 26, 2017

## Preparer/Consultant

Denterprise International, Inc. 100 East Granada Blvd., Suite 219 Ormond Beach, FL 32176

Phone: [phone] Fax: [phone] Primary Contact: Joyce St. Germain, Regulatory Dept. Mgr. ([e-mail]) Secondary Contacts: Claude Berthoin, President ([e-mail]).

#### Device Classification

Trade Name: Common Name: Regulation Name: Regulation Number: Primary Product Code Regulatory Class: 510k Review Panel:

Cocoon Portable Handheld X-ray system Portable x-ray System Extraoral Source X-ray System 21 CFR 872.1800 MUH II Dental

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### Predicate Device

The following predicate was cleared as a Special 510k to the original (K083532) reference predicate.

The following predicate is a legally marketed, post-amendment device:

| 510(k) Number: | K133007 |
|-----------------------|-------------------------------|
| Date Cleared: | April 24, 2014 |
| Device Name: | DX-3000 Portable X-ray System |
| Common Name: | Portable X-ray System |
| Regulation Name: | Extraoral Source X-ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Primary Product Code: | MUH |
| Regulatory Class: | II |
| 510k Review Panel: | Dental |

#### Reference Predicate

| 510(k) Number: | K083532 |
|-----------------------|-------------------------------|
| Clearance Date: | March 10, 2009 |
| Device Name: | ADX4000-L, DX3000-L |
| Common Name: | Portable X-ray System |
| Regulation Name: | Extraoral source X-ray System |
| Regulation Number: | 21 CFR 872.1800 |
| Regulatory Class: | II |
| Primary Product Code: | MUH |

#### Indications for Use

Cocoon is a portable X-ray System indicated for taking diagnostic dental x-rays for both pediatric and adult patients using intraoral film or digital sensors.

#### Intended Use

The Cocoon device is intended for use in dental radiographic examination and diagnosis of the teeth, jaw, and oral structure for both pediatric and adult patients.

#### Device Description

Cocoon Portable X-ray System from Dexcowin Co., Ltd., of Seoul, Korea is a handheld x-ray device. The technology of this device was originally developed in Korea more than a decade ago and global production is still concentrated in that country.

The subject device is designed for dental radiographic examination and diagnosis

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of diseases of the teeth, jaw, and oral structure by exposing an x-ray image receptor to ionizing radiation. The x-ray source, a tube, is located inside the handheld device. All three conventional types of intraoral receptors can be used with this device-analog x-ray film, digital phosphorous plates, and digital x-ray sensors.

## Comparison of Technological Characteristics with Predicate

The following table compares technological and other characteristics of the subject and predicate device.

# Table 5 -- Technological Comparison Subject Models: DX-7017 and DX-7020

| Feature | Cocoon<br>(Subject Device)<br>DX-7017 / DX-7020<br>K173046 | Dexcowin DX3000<br>(Predicate K133007) | Dexcowin DX3000-L<br>(Predicate K083532) |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Indicated for taking<br>diagnostic dental x-rays<br>for both pediatric and<br>adult patients using<br>intraoral film or digital<br>sensors. | Indicated for taking<br>diagnostic dental x-rays<br>for both pediatric and<br>adult patients using<br>intraoral film or digital<br>sensors. | Indicated for taking<br>diagnostic dental x-rays<br>for both pediatric and<br>adult patients using<br>intraoral film or digital<br>sensors. |
| Mechanical | | | |
| Size : Body | 7.6"(H)×5.2"(W)×10.6"(D) | 5.5"(H)×6.5"(W)×3.2"(D) | 5.5"(H)×6.5"(W)×3.2"(D) |
| Weight | 5.0 lbs. (without battery) | 4.4 lbs. (without<br>battery ) | 4.4 lbs. (without<br>battery) |
| Source to<br>skin<br>distance | 180mm | 200mm | 200mm |
| Cone<br>diameter | 58mm | 55mm | 55mm |

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| Exposure<br>switch | On tube-head assembly,<br>or at control panel | On tube-head assembly,<br>or at control panel | On tube-head assembly,<br>or at control panel |
|-----------------------|-----------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------|
| Tube head<br>mounting | Handheld, or on a tripod | Handheld, or on a tripod | Handheld, or on a tripod |
| Electrical | | | |
| Energy<br>Source | Rechargeable 16.8V<br>DC Li-Polymer<br>battery pack | Rechargeable 16.8V<br>DC Li-Polymer battery<br>pack | Rechargeable 16.8V<br>DC Li-Polymer battery<br>pack |
| Exposure<br>Time | 0.05~1.00 seconds in<br>0.001 increments | 0.05~1.35 seconds in<br>0.005 increments | 0.05~1.35 seconds in<br>0.005 increments |
| Timer<br>Accuracy | ±(10% + 1ms) | ±(10% + 1ms) | ±(10% + 1ms) |
| Tube<br>Voltage | 70kVp fixed for<br>DX-7017 and DX-7020 | 60kVp fixed | 60kVp fixed |
| Tube<br>Current | 1.7mA = DX-7017<br>2.0mA = DX-7020 | 2mA fixed | 1mA fixed |

The above comparison shows the subject and predicate devices have substantially the same technology characteristics.

The differences of the subject device are shown in blue highlights as compared to the predicate devices. The differences of the subject are due to design changes and the differences have all been tested according to ISO standards and have proven to be as safe and effective as the previous devices. The indications for use and the technological characteristics are the same in these devices and the subject device does not cause any new issues of concern.

All Standard Test Performed for the Subject Device Models: DX-7017 and DX-7020 are listed below:

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# Declaration of Conformity

- · Council Directive 93/42/EEC as amended by 2007/47/EC of 14 June 1993 concerning medical devices
- MEDDEV 2.12-1 Rev.8 Guidelines on a medical device vigilance system

| No | Standard | Application |
|----|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | EN ISO 13485:2012 | Medical devices - Quality management systems -<br>Requirements regulatory purposes(ISO 13485:2003)<br>EN ISO13485:2003/AC:2007 |
| 2 | EN ISO 14971:2012 | Medical devices - Application of risk management to<br>medical devices(ISO14971:2012) |
| 3 | IEC 60601-1:2005<br>/AMD1:2012 | Medical electrical equipment - part1: General<br>requirements for basic safety and essential<br>performance |
| 4 | IEC 60601-1-2:2007 | Medical electrical equipment - Part1-2:General<br>requirements for basic safety and essential<br>performance - Collateral standard: Electromagnetic<br>compatibility - Requirements and tests |
| 5 | IEC 60601-1-3:2008 | Medical electrical equipment - Part1-3: General<br>requirements for basic safety essential performance -<br>Collateral standard: Radiation protection in diagnostic<br>X-ray equipment |
| 6 | IEC 60601-1-6:2010<br>/AMD1:2013 | Medical electrical equipment-part1-6:General<br>requirements for basic safety and essential<br>performance-Collateral standard: Usability |
| 7 | IEC 60601-2-28:2010 | Medical electrical equipment-part2-28: Particular<br>requirements for the basic safety and essential<br>performance of X-ray tube assemblies for medical<br>diagnosis |
| 8 | IEC 60601-2-65:2012 | Medical electrical equipment-part2-65:Particular<br>requirements for the basic safety and essential<br>performance of dental intra-oral X-ray equipment |
| 9 | IEC 62366-1:2015 | Medical devices-part1: Application of usability |
| | | engineering to medical devices |
| 10 | IEC62304:2015 | Medical device software - software life cycle<br>processes. |
| 11 | ISO 14155-1:2010 | Clinical investigation of medical devices for human<br>subjects |
| 12 | ISO 15223-1:2010 | Medical devices: Symbols to be used with medical<br>devices labels, labeling and information to be supplied |
| 13 | EN1041:2008 | Information supplied by the manufacturer with medical<br>devices |
| 14 | ISO 10993-1:2009 | Biological evaluation of medical devices-Part1:<br>Evaluation and testing within a risk management<br>process |
| 15 | ISO 17050-1:2010 | Conformity assessment-supplier`s declaration of<br>conformity - part 1:General requirements |

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## Non-Clinical Performance Data

The following performance was completed on the subject device in support of the substantial equivalence determination.

- Electrical Safety and EMC 0
- Specifications of Raw Material 0
- Software Validation 0
- Biocompatibility 0
- Usability 0
- Clinical Comparison O
- Risk Assessment O
- All tests were performed in accordance with ISO standards and recognized by 0 FDA.
- None of the standards was adapted for application to the device under review. 0
- There were no requirements of any standard that were not applicable to the 0 device.
- No deviations from the standards were applied. 0

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- No differences exist between the tested device and the device to be marketed. 0
- Conformity with all standards was determined by the device manufacturer, O Dexcowin Co., Ltd., Korea.
- Electrical test performed by Met Laboratories, Inc. O

#### Specific Guidance Document

There is a FDA Specific Guidance Document associated with the device: Radiation Safety Consideration for X-ray Equipment Designed for Hand-Held Use. This submission utilized this guidance to develop this device to ensure the safety of this device for both the operators and the patients.

#### Labels

The labels on the device show that this device conforms to the following:

21 CFR 1020 Subchapter J: Performance Standards for Ionizing Radiation Emitting Products,

21 CFR 1020.30: Diagnostic x-ray systems and their major components,

21 CFR 1020.31: Radiographic Equipment

#### Conclusion

The Cocoon Portable X-ray System shows substantial equivalence to its original predicate and modified predicate devices. All differences were evaluated according to the tests and deemed not to raise new issues of safety or effectiveness. The modifications did not affect the device's intended use or alter the device's fundamental scientific technology. This modified subject device is at least as safe and effective as the predicate devices.