SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,

K042556 · Enter Medical Corporation · BTM · Mar 11, 2005 · Anesthesiology

Device Facts

• Record ID: K042556
• Device Name: SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022,
• Applicant: Enter Medical Corporation
• Product Code: BTM · Anesthesiology
• Decision Date: Mar 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5915
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.

Device Story

ShineBall manual resuscitator is a portable, operator-powered device for emergency lung ventilation. Operator compresses a flexible bag to deliver air to the patient; optional reservoir bag used when supplemental oxygen is supplied. Optional pressure-limiting valve allows control of ventilation pressure based on patient requirements. Available in PVC (single-use) or silicone (reusable/autoclavable) materials. Designed in adult, child, and infant sizes based on body mass. Used by clinicians or emergency responders in emergency settings to support patients with inadequate breathing; helps maintain oxygenation and ventilation.

Clinical Evidence

Bench testing only. Device performance verified against ASTM 920, ISO 8382:1988, and ISO 5356-1:1987. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (skin irritation and sensitization).

Technological Characteristics

Materials: PVC (single-use) or silicone (reusable/autoclavable). Manual operation via compressible bag. Optional pressure-limiting valve. Conical connectors per ISO 5356-1. Complies with ASTM 920 and ISO 8382. No software or electronic components.

Indications for Use

Indicated for individuals of all ages (adult, child, infant) experiencing inadequate breathing in emergency situations requiring manual lung ventilation.

Regulatory Classification

Identification

A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

Predicate Devices

• HEADSTAR Manual Resuscitator (K002846)

Submission Summary (Full Text)

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ENTER MEDICAL COPORATION

No. 16-1, Lane 564, Wen Hua San Road, Gui Shan Xiang,

Tao Yuan Hsien, Taiwan, ROC, 333 Tel: [phone] Fax: [phone]

WAR 1 1 2004

K042556

# ShineBall

510(k) SUMMARY "

Submitter's Name: ENTER Medical Corporation No. 16-1, Lane 564, Wen Hua San Road, Gui Shan Xiang,

Tao Yuan Hsien, 333, Taiwan

Date summary prepared:

September 15, 2004

Device Name:

Proprietary Name:

ShineBall PVC Manual Resusciator, ENT-1001, ENT-1003, ENT-1005 ShineBall Silicone Manual Resusciator, ENT-1022, ENT-1024, ENT-1014 Manual Resusciators

Ventilator, Emergency, Manual ( Resusciator )

Common or Usual Name: Classification Name:

21 CFR 868.5915

Indications for Use:

To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate..

Description of the device:

ShineBall manual emergency resuscitator is a portable device used in life emergency situations to provide lung ventilation to individual whose breathing is inadequate. An optional ShineBall mask is recommended for use with a resuscitator to cover the patient's nose and mouth as a port to receive the patient connector of the resuscitator. A standard reservoir bag is to be used with the ventilation bag when the oxygen gas is supplied to the patient.

The performances of the manual resuscitators are intended for operator-powered Operator-powered resuscitator device is a device by which the ventilation of types. the lung is produced by operator's compressing the air out of the compressible part of the device. To reach the best effect of the clinical situations, adult, child and infant sizes of the resuscitators are designed according to body mass ranges. For safety consideration the pressure limiting valve is designed optionally for those who are not so skillful to operate the device. By adding the pressure limiting valve into the setting of the device, the pressure of the lung ventilation can be controlled easily according to patient's individual requirement.

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#### ENTER MEDICAL COPORATION

No. 16-1, Lane 564, Wen Hua San Road, Gui Shan Xiang,

Tao Yuan Hsien, Taiwan, ROC, 333 Tel: [phone] Fax: [phone]

To lighten the financial burden of the patient or medical facilities, the material of Silicone, which can be autoclaved, is provided for reuse. To lower the cross-infection hazard the material PVC are used for single use and disposable ones.

Performance Testing:

Performance and Specifications of the SnineBall manual emergency resuscitator are consistent with all requirements for this device type specified by:

ASTM 920: Standard Specification for Minimum Performance and Safety Requirements for Resusciators Intended for Use with Humans;

ISO 8382: 1988 (E) : Resusciators Intended for Use with Humans;

ISO 5356-1: 1987: Anesthetic and Respiratory Equipment, Conical Connectors-Part 1 : Cones and Sockets.

Biocompatibility Testing:

All of the SnineBall manual emergency resuscitators passes:

- Cytotoxicity study ISO 10993-5
- Skin irritation study ISO 10993-10
- . Skin sensitization study - ISO 10993-10

Legally marketed device for substantial equivalence comparison:

HEADSTAR Manual Resuscitator ( K002846 )

Conclusion:

The predicate device and the new device are the same technical characteristics. There are including adult, child, and infant sizes. Besides, the material of Silicone, which can be autoclaved, is provided for reuse, the material Rubber for the predicate device and PVC for the new device is used for single use and disposable ones.

The comparison to the predicate device demonstrates that the new device is safe, effective, and is substantially equivalent to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" written around it. Inside the circle is a stylized graphic of three human profiles facing to the right, with wavy lines extending from the bottom of the profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 ] 2005

Mr. Tzong-Fuh Kuo Enter Medical Corporation No. 16-1, Lane 564, Wen Hua San Road Gui Shan Xiang, Tao Yuan Hsien, 333 TAIWAN

Re: K042556

Trade/Device Name: ShineBall PVC Manual Resuscitator, ENT-1001, ENT-1003, ENT-1005 ShineBall Silicone Manual Resusciator, ENT-1022, ENT-1024, ENT-1014 Regulation Number: 868.5915 Regulation Name: Manual Emergency Ventilator Regulatory Class: II Product Code: BTM Dated: January 5, 2005 Received: January 22, 2005

Dear Mr. Fuh Kuo:

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 recencious 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 mensate conniteree prives that have been reclassified in accordance with the provisions of Amendinents, of to arrived Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 writ), it hay of be adjost in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Fuh Kuo

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DT 3 lestained on that your device complies with other requirements mean that FDA nas made a deceminations administered by other Federal agencies. of the Act of ally I edelar statues and regaritements, including, but not limited to: registration 1 out intist comply with and the reveling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), labeling (21 CFR Part 820); and if requirements as set form in the quality sign control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse of substantial equivalence of your device to a premitser notification. - The PDF results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific atvice for Jour at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### ENTER MEDICAL COPORATION

No. 16-1, Lane 564, Wen Hua San Road, Gui Shan Xiang, Tao Yuan Hsien, Taiwan, ROC, 333 Fax: [phone] Tel: [phone]

## Indications for Use

510 (K) NUMBER ( IF KNOW ): __ K042556

DEVICE NAME: ShineBall PVC Manual Resusciator, ENT-1001, ENT-1003, ENT-1005;

ShineBall Silicone Manual Resusciator, ENT-1022, ENT-1024, ENT-1014

#### INDICATIONS FOR USE:

To be used in emergency situations to provide lung ventilation to individuals whose breathing is inadequate.

Prescription Use 1 ----(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices | |
| K Number: | K042556 |