DURQ/ QUALIDURA

K013116 · Ever-Safety Technical Service · BTA · Jan 18, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K013116
• Device Name: DURQ/ QUALIDURA
• Applicant: Ever-Safety Technical Service
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Jan 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

It is designed to improve the disadvantages of the conventional rubber bulb type aspirators with poor suction power , unstable and hard to use. Now no more squeezing by hands or suction by mouth. It removes nasal mucus and fluids from baby's nostrils at home safely and easily.

Device Story

Electric Nose Vacuum (Aspirator) is a battery-operated, handheld device designed for home use to remove nasal mucus from infants. It replaces manual rubber bulb aspirators. The device consists of a pump body, DC motor, and collection cup. Operation involves a push-start momentary switch; the motor creates vacuum pressure (0-45 kPa) to draw fluids into the collection cup through a silicone nozzle. The device is powered by a 4.5V DC supply. It provides a safer, more consistent suction alternative to manual methods, reducing the need for mouth suction or hand squeezing. The healthcare provider or parent uses the device to clear nasal passages, potentially improving infant comfort and breathing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Silicone rubber nozzle (21 CFR 177.2600), PC collection cup (21 CFR 177.2600), TPR button (21 CFR 177.2600), ABS enclosure, POM pump body (21 CFR 177.2470). Powered by 4.5V DC motor (Mabuchi RE-280SA-2865). Vacuum pressure range 0-45 kPa. Handheld form factor. Push-start momentary switch. No software or connectivity.

Indications for Use

Indicated for the removal of nasal mucus and fluids from the nostrils of babies at home.

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.

Reference Devices

• UL 1431 Check List

Submission Summary (Full Text)

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Image /page/0/Figure/0 description: The image shows the logo and contact information for DurQ Machinery Corp. The logo features the name "DurQ" in large, bold letters, with the words "MACHINERY CORP." underneath. The contact information includes the company's address at NO-1448-CHUNG-SAN-RD SHEN KANG HSIANG, TAICHUNG, TAIWAN, R, phone number TEL [phone], fax number FAX:[phone], website URL http://www.durq.com.tw, and email address E-MAIL: [e-mail] tw.

JAN 1 8 2002

KO13116

# 510(k) Summary

(1) Submitter's Name:

Durq Machinery Corp.

Address

No. 1448, Chung San Rd., Shen Kang Hsiang, Taichung, Taiwan, R.O.C Phone: [phone] Fax: [phone] Ray Liao/ R&D Engineer Contact : Summary Prepared Date: Aug. 29, 2001

#### (2) Trade Name and Products

Trade name 1. - Durq Trade name 2. - QualiDura Product - Electric Nose Vacuum (Aspirator) Model No : 02001 Classification name - BTA Powered Pump Aspiration (per 21 CFR section \ 878.4780)

- (3) Reason of Submission: A New Device.

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Image /page/1/Picture/0 description: The image shows the logo for DurQ Machinery Corp. The word "DurQ" is in large, bold, black letters. Below that, the words "Machinery Corp." are spelled out in smaller, spaced-out letters.

and the comments of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first of the first for the first 188年前中部地地址 NO-1448, CHUNG-SANERD SHEN KANG HSIANG, TAICHUNG, TAIWAN, FL : 886-4-2561-3111 FAX:886-4-JRI :http://www.durg.com.tw MAIL:[e-mail].

## (4) Description of the device

Image /page/1/Picture/3 description: This image shows a close-up of a bird's head with numbers pointing to different parts of the bird. The numbers 1, 2, 3, and 4 are pointing to the bird's beak, eye, neck, and body, respectively. The bird is mostly white with some black markings around its eye and beak. The background is dark, which makes the bird stand out.

PORIA
978.4780

Fig. 1

- 1. Material: Silicone Rubber Manufacturer: Silastic Cat. No. : K770 FDA: 21 CFR177.2600
- 2. Collection Cup Material: PC Manufacturer: Lexan Cat. No. : FDA: 21 CFR177.2600

#### 3. Button:

Material: TPR Manufacturer: Sarlink Cat. No. : 3170 FDA: 21 CFR 177.2600

- 4. Enclosure: Material: ABS Manufacturer: Chi Mei Corp.,

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Image /page/2/Picture/0 description: The image shows the logo for DurQ Machinery Corp. The word "DurQ" is in large, bold, black letters. Below that, the words "Machinery Corp." are in smaller, thinner, black letters.

二聖傑機器工業股份有限公司

二台中縣神岡鄉中山路1448號
NO.1448, CHUNG-SAN RD.
SHEN KANG HSIANG, TAICHUNG, TAIWAN, R.
TEL:[phone] FAX:[phone]
URL:http://www.durq.com.tw
E-MAIL [e-mail]

2-3

- (5) Intended use of the device [807.92(a)(5)].
It is designed to improve the disadvantages of the conventional rubber bulb type aspirators with poor suction power , unstable and hard to use. Now no more squeezing by hands or suction by mouth. It removes nasal mucus and fluids from baby's nostrils at home safely and easily.

- (6) Per section 807.92(a)(6), the 510(k) claiming equivalence. N/A
- (7)Substantial equivalence [807.92(b)(1)]. N/A
- (8) Substantial equivalence [807.92(b)(2)]. N/A
- (9) Per section 807.92(b)(3) N/A
- (10) Safety Power:

4.5 V DC Power Supply (without electric shock hazard.)

Vacuum Pressure:

0- 45 kpa (without person injury hazard.)

Contact Nozzle Material :

Silicone Rubber, Cat. No. : K770 by Silastic, are listed in 21CFR177.2600( without poisoned hazard. )

Warning Labeling :

See 3-22 .

Warning provided in Instruction:

See OPERATION MANUAL.

Ref:

5. PERSONAL HYGIENE AND HEALTH CARE APPLIANCES

UL 1431 Check List

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Image /page/3/Figure/0 description: The image shows the logo and contact information for Durq Machinery Corp. The logo features the company name in large, bold letters. Below the logo, the text reads "MACHINERY CORP". The image also includes the company's address, phone number (886-4-2561-3111), fax number (886-4-2561-3589), website (http://www.durq.com.tw), and email address ([e-mail]).

Image /page/3/Figure/1 description: The image shows an exploded view of an automatic air freshener. The components include the batteries, the air freshener refill, and the two halves of the dispenser. The image also includes numbers 1, 2, and 3 pointing to the right of the dispenser.

Image /page/3/Figure/2 description: The image shows the text "Fig. 2" in a simple, sans-serif font. The text is black and appears to be printed on a white background. The figure number is likely a reference to a diagram or illustration within a larger document.

1. Pump Body Material: POM Manufacturer: Polyplastics Co., Ltd., Cat. No. : M90-01 FDA: 21 CR 177.2470

## 2. DC Motor

Manufacturer: Mabuchi Motor Co., Ltd., Cat. No. : RE-280SA-2865 Operating Voltage: 1.5 V - 4.5 V DC Nominal Voltage: 3 V - 4.5 V DC

- 3. DC Momentary Start Switch Manufacturer: Sweeta Products Corporation Cat. No. : PS-22F05 Rating: 50 V DC 0.3 A Operation: Push start(momentary contact).

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Image /page/4/Picture/12 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing the wings and body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 8 2002

Mr. Daniel Yang Ever-Safety Technical Service No. 13, Alley 28, Lane 108 Young Feng Road Taichung Hsien, Taiwan China

Re: K013116

Trade/Device Name: Dura/QualiDura Regulation Number: 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: BTA Dated: December 17, 2001 Received: December 27, 2001

Dear Mr. Yang:

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.

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 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); 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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Page 2 - Mr. Daniel Yang

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

j. Mark N. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| <strong>Labels</strong> | <strong>Values</strong> |
|---------------------------|-------------------------|
| 510(k) Number (if known): | K013116 |
| Device Name: | Electric Nose Vacuum |

Indications For Use:

The ELECTRIC NOSE VACUUM IS

kz Movi 02/14 NE U 0

BAV C EROM 7/11/05 AND NOSTRI

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use

(Optional Format 1-2-96)

Mark A. Mullken

(Division Sign-Off) Division of General, Restorative and I eurological Devices 013114

510(k) Number