CARE SU01A SUCTION ASPIRATOR

K130001 · Foshan Care Medical Technology Co., Ltd. · JCX · Jul 25, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K130001
• Device Name: CARE SU01A SUCTION ASPIRATOR
• Applicant: Foshan Care Medical Technology Co., Ltd.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Jul 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The CARE SU01A Suction aspirator is intended for professional use to remove infectious materials from wounds or fluids from a patient airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.

Device Story

AC-powered suction aspirator; provides general suction in hospitals or clinics. Device generates negative pressure via vacuum pump; pressure manually adjusted via regulating valve and vacuum gauge. Negative pressure transmitted through tubing to collection bottle; aspirates secretions or liquids from patient body. Includes 850ml collection bottle; bacteria filter isolates pump from aspirated fluids; mechanical overflow protection in bottle lid prevents fluid ingress to pump. Operated by healthcare professionals. Benefits patient by clearing airway/respiratory support systems or removing infectious wound materials.

Clinical Evidence

No clinical data. Bench testing only. Compliance with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and ISO 10079-1 (performance requirements for electrically powered suction equipment) confirmed.

Technological Characteristics

AC-powered (120 VAC, 60 Hz) vacuum pump. Max vacuum 560 mmHg. 850ml collection bottle with mechanical overflow protection and bacteria filter. Manual vacuum regulation and gauge. Complies with IEC 60601-1, IEC 60601-1-2, and ISO 10079-1. Non-software controlled.

Indications for Use

Indicated for professional use to remove infectious materials from wounds or fluids from a patient airway or respiratory support unit in adult and pediatric patients.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Suction Unit, Model:SUA01 (K042349)

Submission Summary (Full Text)

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K130001

# JUL 2 5 2013

# 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92

#### Submitter's Information 1.0

### Establishment Registration Name:

Foshan Care Medical Technology Co., Ltd.

The 2F and 3F, G Building, No.1 Huabao Road Southern, Zhangcha, Chancheng District, Foshan, Guangdong, P. R. China 528000

#### Contact Person of applicant

Mr. Gang Wu - Chairman of directors

The 2F and 3F, G Building, No.1 Huabao Road Southern, Zhangcha, Chancheng District, Foshan, Guangdong, P. R. China 528000

TEL: [phone] FAX: [phone] Email: [e-mail]

### Contact Person of the Submission:

Ms. Kathy Guo

Foshan Care Medical Technology Co., Ltd.

The 2F and 3F, G Building, No.1 Huabao Road Southern, Zhangcha, Chancheng District, Foshan, Guangdong, P. R. China 528000

Email: [e-mail]

#### Device Information 2.0

| Type of 510(k) submission: | Traditional |
|----------------------------|--------------------------------------------------------|
| Device Common Name: | Power Suction Unit |
| Trade Name: | Model SU01A Suction aspirator |
| Model: | SU01A |
| Classification name: | Apparatus, Suction, Ward Use, Portable, AC-<br>Powered |
| Review Panel: | General & Plastic Surgery |

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| Product Code: | JCX |
|--------------------|----------|
| Regulation Class: | II |
| Regulation Number: | 878.4780 |

#### Predicate Device Information 3.0

| Sponsor: | EMG Technology Company, Ltd |
|-----------------------|-----------------------------|
| Device: | Suction Unit, Model:SUA01 |
| 510(K) Number: | K042349 |
| Product Code: | JCX |
| Regulation Class: | II |
| Regulation<br>Number: | 878.4780 |

#### Device description 4.0

Powered suction pumps are described in FDA regulations, 21 CFR 878.4780, as:

"A powered suction pump is an AC-powered device intended to be used to remove infectious materials from wounds or fluids from patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter. The FDA classified the device as a class II medical device".

The SU01 A Suction aspirator is designed to provide general suction for use in hospitals or clinics. This Suction aspirator is a professional medical suctioning device that produces a maximum vacuum of 560 mmHg. It is used with a power supply allowing operation on AC voltage (120 VAC, 60 Hz). The device is equipped with 850ml collection bottle and has been designed for convenient and reliable and reliable usages.

The vacuum pump of the SU01A transmits negative pressure throughout the tubing-system and the collection bottle to patient tubing that aspirates secretions or liquid form the body. The vacuum pump can be manually adjusted using the regulating value and the vacuum gage. The aspirated fluids are collected in the collection bottle that is isolated from the pump by a bacteria filter. It also has a mechanical overflow protection in the lid of the collection bottle to further prevent the fluids from being sucked into the pump.

#### Intended Use 5.0

The CARE SU01A Suction aspirator is intended for professional use to remove infectious materials from wounds or fluids from a patient airway or respiratory support unit. The intended large population for this device is both adult and pediatric patients.

#### Determination of Substantial Equivalence 6.0

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## Summary of Technological Characteristics of the Device Compared to the Predicate Device

The CARE SU01 A Suction aspirator uses the same fundamental technology as the EMG SUA01 Suction Unit for most features. The indications for use of CARE SU01A Suction aspirator are the same as EMG SUA01 Suction Unit. CARE SU01A Suction aspirator is similar to the predicate devices in its indications for use and patient population. The user interface is also similar to the predicated devices. The main difference is in the volume of the collection bottle, which is increased but still sufficient for the expected daily volumes. The smaller size improves mobility.

### Summary of Non-clinical Tests:

The CARE SU01 A Suction aspirator complies with voluntary standards for electrical safety, electromagnetic compatibility, and performance. The following quality assurance measures were applied to the development of the system:

- Electrical safety and electromagnetic compatibility testing per IEC 60601-1 ● and IEC 60601-1-2 standards, respectively
- Medical suction equipment Part 1 : Electrically powered suction equipment -● Safety requirements per ISO 10079-1

### Summary of Clinical Tests:

No clinical studies were performed

### CONCLUSION:

Foshan Care considers the SU01 A Suction aspirator to be as safe, as effective, and substantially equivalent to the predicate devices.

#### 7.0 Effectiveness and Safety Considerations

#### Effectiveness:

The SU01 A Suction aspirator complies with ISO10079-1:1999.

### Safety Considerations:

The applicant devices comply with IEC60601-1, Medical electrical equipment - Part l : General requirements for safety and IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests.

The SU01A Suction aspirator is not a software controlled medical device, the software test according the software guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is not applicable.

The accessories which contact the patients directly are provided by the hospital but not the manufacture. All the accessories of the SU01 A Suction aspirator are not contact the patients, the biocompatibility test is not applicable.

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The clinical performance test is not applicable

#### Comparison to predicate device and conclusion 8.0

### Comparison Analysis

The applicant device has same classification information, same indications and intended use, similar product design, similar technical specification and safety specification.

| | SU01A Suction | SUA01 Suction | Results |
|-------------------------------|---------------|---------------|---------|
| Attribute | Pump | Unit | |
| The pump shall be compliant | Meet the | Meet the | Pass |
| with IEC 60601-1 | requirements | requirements | |
| requirements | | | |
| The pump shall be compliant | Meet the | Meet the | Pass |
| with IEC 60601-1-2 | requirements | requirements | |
| requirements | | | |
| The pump shall be compliant | Meet the | Meet the | Pass |
| with ISO 10079-1 | requirements | requirements | |
| requirements | | | |
| The pump controls shall be | Meet the | Meet the | Pass |
| easily identifiable by user | requirements | requirements | |
| The Collection Bottle should | 850ml | 800ml | Pass |
| have volume reference | | | |
| markings | | | |
| The Collection Bottle should | Meet the | Meet the | Pass |
| be able to withstand | requirements | requirements | |
| maximum pressure delivered | | | |
| by the pump | | | |
| The degree of collapse of the | Less than 0,5 | Less than 0,5 | Pass |
| tubing shall be less than 0,5 | | | |
| throughout its entire length | | | |
| when subjected to the | | | |
| maximum vacuum stated | | | |
| The resistance to implosion | Meet the | Meet the | Pass |
| for collection container | requirements | requirements | |
| The flow rate of maximum | Meet the | Meet the | Pass |
| pumping power | requirements | requirements | |

#### Conclusion:

The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally marketed device. Therefore, the applicant device is determined as safe and effectiveness.

Compare with predicate device, they are very similar in design principle, intended use, functions, material and the adopting applicable standards. The differences between applicant device and predicate device do not raise any new questions of safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Foshan Care Medical Technology Co., Ltd. % Regulatory Technology Services, LLC Mr. Mark Job 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K130001

Trade/Device Name: Care SU01A Suction Aspirator Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: July 16, 2013 Received: July 17, 2013

Dear Mr. Job:

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

July 25, 2013

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Page 2 - Mr. Mark Job

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/ucm 1 15809.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/ResourcesforYou/Industry/default.htm.

FOR

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Statement of Indications for Use

510(k) Number (if known): JS known): Suction aspirator Suction aspirator Device Name: SU01A Model:

Indications for Use:

The CARE SU01A Suction aspirator is intended for professional use to remove infectious The CARD DOGTT Caction abplaison a patient airway or respiratory support unit. The materials from Woulds of for this device is both adult and pediatric patients.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1 =

| DSD-DIVISION SIGN-OFF | |
|------------------------------|---------------------|
| Division of Surgical Devices | |
| 510(k) Number: | K130001 |
| | Joshua C. Nipper -S |