ZOOM Aspiration Pump

K190105 · Taiwan Biomaterial Co., Ltd. · JCX · Feb 21, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K190105
• Device Name: ZOOM Aspiration Pump
• Applicant: Taiwan Biomaterial Co., Ltd.
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Feb 21, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

ZOOM Aspiration Pump The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics. ZOOM Canister The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump. ZOOM Aspiration Tubing The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

Device Story

AC-powered oil-less positive displacement pump; delivers vacuum (0-29 inHg) for removal of bodily fluids. Components: pump housing with power button, vacuum regulator, analog pressure gauge, sliding canister shelf; 1000 mL single-use canister; sterile single-use aspiration tubing. Used in hospitals or clinics by healthcare professionals. User connects suction catheter to canister via tubing; adjusts vacuum level via regulator; monitors pressure via analog gauge. Canister collects fluids; overflow protection valve and filter prevent fluid ingress into pump. Benefits: provides consistent vacuum for fluid removal during clinical procedures.

Clinical Evidence

Bench testing only. No clinical data. Performance testing conducted per FDA guidance for Powered Suction Pumps, including IEC 60601-1, IEC 60601-1-2, ISO 10079-1, and IEC 60529. Biocompatibility testing performed per ISO 10993-1. All tests passed acceptance criteria.

Technological Characteristics

AC-powered oil-less positive displacement pump. Vacuum range: 0-29 inHg. Flow rate: 0-0.8 SCFM (0-23 LPM). Dimensions: 12.3in x 7.2in x 12.4in. Weight: 15.2 lb. Accessories: 1000 mL single-use canister, EO-sterilized aspiration tubing. Standards: ANSI/AAMI ES60601-1, CAN/CSA C22.2 NO. 60601-1, IEC 60601-1-2, ISO 10079-1, IEC 60529 (IP21), ISO 10993-1. Non-sterile pump; sterile tubing.

Indications for Use

Indicated for general suction use in hospitals or clinics for the removal of bodily fluids.

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

• TWBM Pump (K180115)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 21, 2019

Taiwan Biomaterial Co., Ltd. Monoj Kalita Deputy Manager, Regulatory Affairs 6F, No. 26-1, Sec.2, Shengyi Rd. Zhubei. 30261 Taiwan

Re: K190105

Trade/Device Name: ZOOM Aspiration Pump Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: Class II Product Code: JCX Dated: January 18, 2019 Received: January 22, 2019

Dear Monoj Kalita:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by David David Krause -S Krause -S Krause -S
Date: 2019.02.21 14:10:37 -05'00

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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K190105

Device Name

ZOOM Aspiration Pump

Indications for Use (Describe)

ZOOM Aspiration Pump The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics.

ZOOM Canister

The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump.

ZOOM Aspiration Tubing

The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K190105

## ZOOM™ Aspiration Pump

Special 510(k)

## 510(K) SUMMARY

#### 1.1. APPLICANT INFORMATION

| Applicant Name | ---- Taiwan Biomaterial Co., Ltd. (TWBM) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Address | ---- 6F, No. 26-1, Sec.2, Shengyi Rd., Zhubei City, Hsinchu County<br>30261, Taiwan. |
| Telephone | ---- [phone] |
| Fax | ---- [phone] |
| Contact Person | ---- Monoj Mon Kalita, Ph.D.<br>Deputy Manager, Regulatory Affairs<br>Phone: [phone] ext. 309<br>Email: [e-mail] |
| Date Prepared | ---- February 5, 2019 |

#### SUBJECT DEVICE 1.2.

| Trade Name | ---- ZOOM™ Aspiration Pump |
|---------------------|---------------------------------------------------------|
| Common/Usual Name | ---- Powered Suction Pump |
| Device Class | ---- Class II |
| Regulation Number | ---- 21 CFR 878.4780 |
| Classification Name | ---- Apparatus, Suction, Ward Use, Portable, AC-Powered |
| Product Code | ---- JCX |

### PREDICATE DEVICE NAME 1.3.

TWBM Pump (K180115)

#### 1.4. INTENDED USE

### ZOOM Aspiration Pump

The ZOOM Aspiration Pump is intended for general suction use in hospitals or clinics.

### ZOOM Canister

The ZOOM Canister is intended to collect aspirated fluids for disposal and prevent fluid ingress from damaging the ZOOM Aspiration Pump.

### ZOOM Aspiration Tubing

The ZOOM Aspiration Tubing Set is intended to connect a suction catheter to the ZOOM Canister of the ZOOM Aspiration Pump and to allow the user to control the fluid flow.

{4}------------------------------------------------

Special 510(k)

# ZOOM™ Aspiration Pump

#### 1.5. DEVICE DESCRIPTION

The ZOOM™ Aspiration Pump (ZOOM Pump) is an AC powered oil-less positive displacement pump capable of consistently delivering vacuum (0-29 inHg) for the removal of bodily fluids. The ZOOM Pump housing is fitted with a power (ON/OFF) button, one vacuum regulator, an analog pressure gauge and sliding canister shelf. The ZOOM Pump is provided non-sterile.

There are two accessories for the ZOOM Pump, the ZOOM™ Canister and ZOOM™ Aspiration Tubing. The ZOOM™ Canister is a non-sterile, single use 1000 mL canister which collects the removed bodily fluids. The ZOOM Canister is positioned in the sliding canister shelf and connected to the ZOOM Pump via the canister tubing and connectors. The ZOOM Aspiration Tubing is sterile, single use and connects to the blue connector on the canister lid.

## 1.6.

## TECHNOLOGICAL AND REGULATORY ATTRIBUTES COMPARISON

The technological and regulatory attributes of the subject device are compared with the predicate device as illustrated in the table below:

| Attributes | TWBM Pump<br>(Predicate Device) | ZOOM™ Aspiration Pump<br>(Subject Device) |
|------------------------|-------------------------------------------------------|-------------------------------------------|
| 510(k) Number | K180115 | K190105 |
| Classification Name | Apparatus, Suction, Ward Use,<br>Portable, AC-Powered | Same as predicate |
| Class | II | Same as predicate |
| Product Code | JCX | Same as predicate |
| Intended Use | General suction use in hospitals<br>or clinics | Same as predicate |
| Product Type | AC-Powered suction pump | Same as predicate |
| Manufacturer | TWBM | Same as predicate |
| Electrical requirement | 110-120Vac<br>60Hz | Same as predicate |
| Flow Rate | 0-0.8 SCFM (0-23 LPM) | Same as predicate |
| Vacuum Range | 0-29 inHg (0-737mmHg) | Same as predicate |
| Noise level | <60dB | Same as predicate |

{5}------------------------------------------------

# ZOOM™ Aspiration Pump

Special 510(k)

| Attributes | TWBM Pump<br>(Predicate Device) | ZOOM™ Aspiration Pump<br>(Subject Device) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | 12.2in×6.2in×11.3in<br>(30.9cm×15.7cm×28.7cm) | 12.3in×7.2in×12.4in<br>(31.3cm×18.3cm×31.5cm) |
| Weight | 14.8 lb (6.7 kg) | 15.2 lb (6.9 kg) |
| Duty Cycle | 45 min (20%) ON/ 3 hours (80%)<br>OFF | 45 min (97.8%) ON/ 1 min (2.2%)<br>OFF |
| Accessories | Canister<br>• TWBM Canister 1000 mL,<br>• Canister tubing,<br>• Overflow protection valve,<br>• Filter (Microbial, Hydrophobic),<br>• Single Use Only,<br>• Non-Sterile | ZOOM™ Canister<br>• ZOOM™ Canister 1000 mL,<br>• Canister tubing,<br>• Overflow protection valve,<br>• Filter (Microbial, Hydrophobic),<br>• Single Use Only,<br>• Non-Sterile |
| | Aspiration Tubing<br>N/A | ZOOM™ Aspiration Tubing<br>• Class II Exempt<br>• EO Sterilized<br>• Non-pyrogenic<br>• Biocompatible<br>• Single Use Only<br>• ID: 0.110"<br>• Length: 264.2cm<br>• Flow clamp |
| Operating Environment | Temp: 65°F~75°F (18°C~ 24°C)<br>Humidity: <75% RH<br>Pressure: Sea Level - 6000 ft<br>(1829m) | Same as predicate |
| Storage Environment | Temp: -20°F~120°F (-29°C~<br>49°C)<br>Humidity: <95% RH | Same as predicate |

{6}------------------------------------------------

# ZOOM™ Aspiration Pump

#### 1.7. SUMMARY OF DEVICE TESTING

ZOOM™ Aspiration Pump was subjected to Electromagnetic Compatibility testing in accordance with IEC 60601-1-2 and performance bench testing in accordance with ISO 10079-1, IEC 60601-1 as well as IEC 60529. Testing for ZOOM™ Aspiration Pump were conducted by following the FDA's "Guidance Document for Powered Suction Pump 510(k)s" (Sept. 30, 1998). All the test results from the performance testing passed the acceptance criteria set forth by the respective standards.

#### 1.8. SUMMARY OF NON-CLINICAL TESTING

The table below highlights the non-clinical performance testing of the ZOOM™ Aspiration Pump and its accessories, conducted for the determination of substantial equivalence with the predicate TWBM Pump and its accessory.

| Attributes | Acceptance Criteria | Result<br>(YES/NO) |
|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------|
| ZOOM™ ASPIRATION PUMP | | |
| Compliance with ANSI/AAMI ES60601-1 and<br>CAN/CSA C22.2 NO. 60601-1 | 100% Pass | YES |
| Compliance with IEC 60601-1-2 | 100% Pass | YES |
| Compliance with ISO 10079-1 | 100% Pass | YES |
| Compliance with IEC 60529 for IP Code | The requirement for the IP<br>21 marking should be met. | YES |
| ZOOM™ CANISTER (COMPLIANCE WITH ISO 10079-1) | | |
| Design and Operational Requirements for<br>ZOOM™ Canister and its Components | 100% Pass | YES |
| ZOOM™ ASPIRATION TUBING | | |
| Operational Requirements for ZOOM™<br>Aspiration Tubing and its Components<br>(Compliance with ISO 10079-1) | 100% Pass | YES |
| Compliance ISO 10993-1 | Biocompatible | YES |

{7}------------------------------------------------

Special 510(k)

## ZOOM™ Aspiration Pump

## CONCLUSION

1.9.

Both the ZOOM™ Aspiration Pump as well as the predicate TWBM Pump are AC-Powered Suction Pumps with similar accessories for fluid containment. Additionally, the non-clinical bench testing results and the comparison of technological characteristics, intended use, the principle of operation and operating environment support the determination of ZOOM™ Aspiration Pump to be substantially equivalent to the predicate TWBM Pump. It can be concluded that the subject device performs as safe and effective as the predicate device.