Spectra S3 Plus

K181784 · Uzinmedicare Co. · HGX · Nov 30, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K181784
• Device Name: Spectra S3 Plus
• Applicant: Uzinmedicare Co.
• Product Code: HGX · Obstetrics/Gynecology
• Decision Date: Nov 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5160
• Device Class: Class 2

Intended Use

The Spectra 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

Device Story

Powered breast pump; expresses/collects milk from lactating women. Operates via diaphragm pump mechanism; user-controlled via buttons on device interface. Features two modes: massage (5 suction levels, 1 cycle speed) and expression (12 suction levels, 5 cycle speeds). Vacuum range 50-270 mmHg; cycle rates up to 70 cycles/min. Powered by 12V DC adapter or rechargeable lithium battery. Used in hospitals (multi-user) or homes (single-user). User adjusts vacuum/cycle settings via LCD display; output is expressed milk collected in bottles. Benefits include efficient milk expression for breastfeeding women. Single-user kits required for hygiene.

Clinical Evidence

Bench testing only. Performance data included vacuum testing (single/double pumping, AC/battery), battery usage duration, cycle rate verification, breast shield size compatibility, and backflow protection efficacy.

Technological Characteristics

Powered diaphragm breast pump. Materials include silicone membrane for backflow protection. Dimensions/form factor: portable unit with LCD display, buttons, and night light. Power: 12V DC adapter or 11.1V 2000mAh rechargeable Li-Polymer battery. Connectivity: None. Software: Embedded firmware for mode/vacuum/cycle control. Sterilization: Not specified (multi-user cleaning instructions provided).

Indications for Use

Indicated for lactating women to express and collect breast milk. Intended for multiple-user use in hospital settings and single-user use in home settings.

Regulatory Classification

Identification

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

Predicate Devices

• Spectra S1 Plus Breast Pump (K150476)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 30, 2018

Uzinmedicare Co. % Adrienne R. Lenz Senior Medical Device Regulation Expert Hyman, Phelps, & McNamara, P.C. 700 Thirteenth N.W., Suite 1200 Washington, D. C. 20005

Re: K181784

Trade/Device Name: Spectra S3 Plus Breast Pump Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: October 30, 2018 Received: October 31, 2018

Dear Adrienne R. Lenz:

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.

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

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 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.

# Michael T. Bailey -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K181784

Device Name Spectra S3 Plus Breast Pump

Indications for Use (Describe)

The Spectra 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

X 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 [e-mail]

"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}------------------------------------------------

#### 510(k) Summary - K181784

In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:

DATE PREPARED: November 30, 2018

#### SUBMITTER:

#### UZINMEDICARE CO

Room 105, Joongang Induspia V, Sagimakgolo 137, Jungwon-gu, Seoungnam-Si, Gyeonggi-do, 13202, South Korea

#### PRIMARY CONTACT PERSON:

Nathan Ahn, Manager Overseas Department c/o UZINMEDICARE CO Room 105, Joongang Induspia V, Sagimakgolo 137, Jungwon-gu, Seoungnam-Si, Gyeonggi-do, 13202, South Korea Telephone: [phone] Email: [e-mail]

#### SECONDARY CONTACT PERSON:

Heidi Humphries, RN, BSN, IBCLC Spectra Baby USA 6851 SW 21ST Court, Suite 1 Davie, FL 33317 Telephone: [phone] E-mail: [e-mail]

#### DEVICE:

TRADE NAME: Spectra S3 Plus Breast Pump COMMON/USUAL NAME: Breast Pump REGULATION NAME: Powered Breast Pump REGULATION NUMBER: 21 CFR 884.5160

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

REVIEW PANEL: Obstetrics/Gynecology PRODUCT CODE: HGX (pump, breast, powered) REGULATORY CLASS: II

#### PREDICATE DEVICE(S):

K150476 Spectra S1 Plus Breast Pump The predicate device has not been subject to a design related recall.

#### DEVICE DESCRIPTION:

The Spectra S3 Plus is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to switch from massage mode to expression mode, and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed option, while expression mode has 12 suction levels and 5 cycle speed levels. The Spectra S3 Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute. The Spectra S3 Plus is powered by a 12V DC adaptor or rechargeable lithium battery.

The Spectra S3 Plus breast pump can be used by multiple users. Kits used with the Spectra S3 Plus breast pump, however, are labeled for a single user.

## INDICATIONS FOR USE:

The Spectra S3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra S3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

## PREDICATE DEVICE COMPARISION:

As summarized in the table below, the subject and predicate device have the same intended use - express and collect breast milk. Regarding technological characteristics, the only substantive difference between the subject and predicate device is that the subject device pump is for use by multiple users while the predicate device is for use by a single user. This difference in technological characteristics does not raise different questions of safety or effectiveness.

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

| | Spectra S1 Plus Breast Pump<br>Predicate Device (K150476) | Spectra S3 Plus Breast Pump |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient<br>Population | Breastfeeding women | Breastfeeding women |
| Indications<br>for Use | The Spectra S1 Plus is a single-<br>user powered breast pump<br>intended to express and collect<br>milk from the breasts of lactating<br>women. | The Spectra S3 Plus Breast Pump<br>is a powered breast pump to be<br>used by lactating women to<br>express and collect milk from their<br>breast. The Spectra S3 Plus Breast<br>Pump is intended for multiple<br>users in a hospital setting. It is<br>also intended for home use by a<br>single user. |
| Use Type | Single user | Multi-user and single user |
| Environment<br>of Use | Home | Hospital, Home |
| User Interface | LCD display, buttons, night light | LCD display, buttons, night light |
| Modes of<br>Operation | Massage, Expression | Massage, Expression |
| Single/Double<br>Pumping | Single or Double | Single or Double |
| Accessories | Breast shield set, includes<br>flange (28 mm) backflow protector valve tubing 12V AC Power adapter<br>Bottle Set (bottle, nipple, cap,<br>disk, cover) | Breast shield set, includes<br>flange (size 20, 24, 28 and 32 mm) backflow protector valve tubing 12V AC Power adapter<br>Bottle Set (bottle, nipple, cap,<br>disk, cover) |
| Pump Type | Diaphragm | Diaphragm |
| Suction<br>Levels | 12 Levels | 12 Levels |
| Suction<br>Strength | $50 (\pm 50) $ mmHg to 270 (-50<br>mmHg) (maximum 270 mmHg) | $50 (\pm 50) $ mmHg to 270 (-50<br>mmHg) (maximum 270 mmHg) |
| | Spectra S1 Plus Breast Pump<br>Predicate Device (K150476) | Spectra S3 Plus Breast Pump |
| Cycle Speed | 38-70 cycles/min (adjustable) | 38-70 cycles/min (adjustable) |
| Power Supply<br>(Conventional<br>Outlet) | AC/DC wall converter<br>Input 100V – 240AC, 50/60Hz,<br>600mA<br>Output: 12V, 2A | AC/DC wall converter<br>Input 100V – 240AC, 50/60Hz,<br>600mA<br>Output: 12V, 2A |
| Power Supply<br>(Battery) | Rechargeable Lithium Ion Battery<br>11.1V 2000mAh Li-Polymer | Rechargeable Lithium Ion Battery<br>11.1V 2000mAh Li-Polymer |
| Back Flow<br>Protection | Yes, provided by silicone<br>membrane backflow protector | Yes, provided by silicone<br>membrane backflow protector |
| Software | Yes | Yes |

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

# SUMMARY OF PERFORMANCE DATA:

# SUMMARY OF NON-CLINICAL TESTS:

As stated previously, the only substantive difference between the subject and predicate device is that the subject device is a multi-user pump. Therefore, the subject device leverages performance data conducted on the predicate device. The following new performance tests were conducted on the subject device:

- Vacuum test (battery and AC) to demonstrate that the pump vacuum meets . specifications during single pumping and double pumping with battery or AC power (110 VAC, 60 Hz),
- Battery usage test to demonstrate battery usage time, ●
- Cycle test to demonstrate that the pump cycle rate meets specifications while ● running on battery or AC power,
- Breast shield size test to demonstrate that the pump meets vacuum specifications . with all breast shield sizes,
- Backflow protection test to demonstrate that milk cannot flow through the ● backflow protector into the breast pump.

In addition, the labeling was updated to reflect use by multiple users and to include

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

corresponding warnings, precautions, and cleaning instructions.

## CONCLUSION:

The performance data demonstrates that the Spectra S3 Plus breast pump is substantially equivalent to the predicate device.