SPECTRA SERIES BREAST PUMP

K093145 · Uzinmedicare Co. · HGX · Aug 13, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K093145
• Device Name: SPECTRA SERIES BREAST PUMP
• Applicant: Uzinmedicare Co.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Spectra electric breast pump is Single user product and intended to express breast milk from the breast of lactating woman.

Device Story

Spectra Series Breast Pump is an AC-powered, piston-driven device designed to express breast milk. It utilizes an AC motor to drive a piston pump, generating a vacuum that is transmitted through air tubing to a breast shield applied to the user's breast. The device allows for adjustable vacuum levels to facilitate milk expression. It is intended for use by lactating women. The device features overflow protection and supports both single and double pumping configurations. The user operates the device by adjusting vacuum settings to control the suction intensity. By creating a controlled vacuum, the device assists in the expression of breast milk, potentially benefiting the user by facilitating milk collection.

Clinical Evidence

Bench testing only. No clinical data provided. Testing demonstrated that the device meets established requirements for safety and performance when used as specified in the labeling.

Technological Characteristics

Powered breast pump (21 CFR 884.5160); AC motor-driven piston pump; vacuum range 150-400 mmHg; cycle speed 46-47 cycles/min; supports single/double pumping; includes overflow protection; weight 2.1 kg.

Indications for Use

Indicated for lactating women to express breast milk. Single-user product.

Regulatory Classification

Identification

A powered breast pump in an electrically powered suction device used to express milk from the breast.

Predicate Devices

• Playtex Embrace Petite Breast Pump (K061013)
• Medela Lactina Plus (K950750)
• Ameda Purely Yours (K973501)

Submission Summary (Full Text)

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K093145 page 1 of 3

### 510(k) SUMMARY of Safety and Effectiveness

The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):

AUG 1 3 2010

## 1.Submitter's Information

UZINMEDICARE CO.

503-2, Chang-Ri, Namsa-Myeon, Yongin, Kyeonggi-Do, Korea, Zip:449-885 Phone : [phone]

### 2. Contact Name

Yong J. Choi Name:

Title : Manager

Address: 503-2, Chang-Ri, Namsa-Myeon, Yongin, Kyeonggi-Do, Korea,

Zip 449-885

Phone No.: [phone]

Fax No .: [phone]

E-Mail: [e-mail]

Contact person in U.S.

Name: DANIEL MIN

Address: 904-274th Way SESAMMAMISH, WA 98075, USA

Phone No .: 1- 206-510-8006

Fax No.: 1-428-369-8795

E-Mail: [e-mail]

#### 3. Device Identification

Proprietary Name: Spectra Series Breast Pump Common/Usual Name: Powered Breast Pump Classification Name: Powered Breast Pump per 21 CFR § 884.5160 Product Code: HGX

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# 4.Classification of Device

FDA has classified the predicate devices(K061013, K950750, K973501) as class II, CFR § 884.5160. It is our understanding that the powered breast pump fall under the same classification, Sec. § 884.5160 as the predicate devices.

### 5.Reason for 510(k) Submission

Initial Product Introduction is the reason for submitting the 510(k).

#### 6. Identification of legally marketed predicate device

The subject device is deemed to be substantially equivalent to those following devices manufactured and currently available in commercial distribution.

| | Uzinmedicare<br>Spectra Series | Playtex<br>Embrace Petite<br>Breast Pump | Medela Lactina<br>Plus | Ameda Purely<br>Yours |
|--------------------------------------|--------------------------------|------------------------------------------|------------------------|-----------------------------------------|
| 510(k) Number | N/A | K061013 | K950750 | K973501 |
| Intended Use | To Express Milk | To Express Milk | To Express Milk | To Express Milk |
| Power Source | AC Power Supply | DC Power<br>Supply | AC Power<br>Supply | DC Power<br>Supply or 6 AA<br>Batteries |
| Pump Type | Piston | Piston | Piston | Piston |
| Single or Double<br>Pumping | Both | Both | Both | Both |
| Adjustable Suction<br>Levels | Yes | Yes | Yes | Yes |
| Adjustable Cycle<br>Speed | No | No | No | Yes |
| Overflow Protection | Yes | Yes | No | Yes |
| Highest Vacuum<br>Setting(mmHg) | 400 Less than | 214 | 240 | 163 |
| Lowest Vacuum<br>Setting(mmHg) | 150 | 72 | 100 | 21 |
| Range of Cycle<br>Speeds(Cycles/min) | 46-47 | 45 | 66-41 | 67-29 |
| Weight (Kg) | 2.1 | - | 2.4 | - |

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#### 7. Description of Device

The Spectra Series Breast Pump is operated by AC motor, The device's motor drives a Piston pump, creating a vacuum to express breast milk. Passing through an air tubing to breast shield, the vacuum is used to comfortably draw out the breast milk.

This device operates with power ON at the same time. Also, vacuum regulate operates, and I adjust a vacuum. ON, OFF of a device means opening of absorption and end.

Regular this which is international or foods of FDA shall obey it to safe sanitary rules etc. related to contacts of mother's milk that I faced it to things come in contact on matter or human chest etc.

#### 8. Indications for Use

The Spectra electric breast pump is intended to express breast milk from the breast of lactating woman.

#### 9. Discussion of Non Clinical Tests

All testing of this subject device has demonstrated that the Spectra Series breast pump meets established requirements when used in the manner and environment specified in product labeling.

#### 10.Conclusion

The Spectra Series Breast Pump has the same intended use and similar technological characteristics as the predicate devices. Thus, we are claiming that the Spectra Series Breast Pump is substantially equivalent to the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.

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

Yong J. Choi Manager Uzinmedicare Co. 503-2, Chang-Ri, Namsa-Myeon Yongin-Si, Kyeonggi-Do 449-885, KOREA

Re: K093145

Trade Name: Spectra Series Breast Pump

Regulation Number: 21 CFR 8884.5160 . Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: May 20, 2010 Received: May 21, 2010

#### Dear Mr. Choi:

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 of medical device-related

AUG 1 3 2010

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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/CDRHOffices/ucm115809.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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Hubert Lenoir MD

erbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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**Uzinmedicare Co.**

503-2,Chang-Ri, Namsa-Myeon, Yongin-Si, Kyeonggi-Do 449-885, Korea Tel.[phone]/Fax.[phone]

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Image /page/5/Picture/3 description: The image shows the logo for Spectra. The logo is in a black oval shape with the word "spectra" written in white letters inside. The "C" in "spectra" is capitalized. The logo is surrounded by a black border.

#### Indications for Use

510(k) Number (if known): K093145 AUG 1 3 2010

Creative Studio

Device Name:

Spectra Series Breast Pump

Indications for Use:

The Spectra electric breast pump is Single user product and intended to express breast milk from the breast of lactating woman.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K093145