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 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.

AI/ML Overview

This is a summary of the provided text, focusing on acceptance criteria and study details.

The document is a 510(k) premarket notification for the Spectra S3 Plus Breast Pump. It aims to demonstrate substantial equivalence to a predicate device (Spectra S1 Plus Breast Pump, K150476).

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly outline specific "acceptance criteria" in a quantitative, pass/fail table format with reported performance. Instead, it states that the conducted tests demonstrate the device "meets specifications" or "demonstrates" certain functionalities. The comparison table with the predicate device implies that functional equivalence to the predicate is the primary acceptance criterion for most features, with specific new tests for the multi-user aspect.

Here's an interpreted table based on the provided "Summary of Non-Clinical Tests" and the predicate comparison:

Acceptance Criterion (Implied)	Reported Device Performance (Spectra S3 Plus Breast Pump)
Functional Equivalence to Predicate Device:
- Intended Use: Express and collect breast milk.	Same intended use as predicate.
- Patient Population: Breastfeeding women.	Same patient population as predicate.
- User Interface: LCD display, buttons, night light.	Same as predicate.
- Modes of Operation: Massage, Expression.	Same as predicate.
- Single/Double Pumping capability.	Same as predicate.
- Accessories (e.g., breast shield set, AC adapter, bottle).	Includes breast shield set (flange sizes 20, 24, 28, 32 mm), backflow protector, valve, tubing, 12V AC power adapter, bottle set. (Expands flange sizes from predicate)
- Pump Type: Diaphragm.	Same as predicate.
- Suction Levels: 12 levels.	Same as predicate.
- Suction Strength: 50 (±50) mmHg to 270 (-50 mmHg).	Meets these specifications.
- Cycle Speed: 38-70 cycles/min (adjustable).	Meets these specifications.
- Power Supply (Conventional Outlet).	AC/DC wall converter (Input 100V – 240AC, 50/60Hz, 600mA; Output: 12V, 2A). Same as predicate.
- Power Supply (Battery).	Rechargeable Lithium Ion Battery (11.1V 2000mAh Li-Polymer). Same as predicate.
- Backflow Protection.	Yes, provided by silicone membrane backflow protector. Same as predicate.
- Software.	Yes. Same as predicate.
Specific Acceptance Criteria for Multi-User Addition:
- Vacuum performance with battery and AC power	Demonstrated that the pump vacuum meets specifications during single pumping and double pumping with battery or AC power (110 VAC, 60 Hz).
- Battery usage time	Demonstrated battery usage time. (Specific values not provided in this summary).
- Cycle rate with battery and AC power	Demonstrated that the pump cycle rate meets specifications while running on battery or AC power.
- Vacuum performance with all breast shield sizes	Demonstrated that the pump meets vacuum specifications with all breast shield sizes.
- Backflow protection effectiveness	Demonstrated that milk cannot flow through the backflow protector into the breast pump.
- Labeling for multi-user use	Updated to reflect use by multiple users and to include corresponding warnings, precautions, and cleaning instructions.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size for any of the non-clinical tests performed. It also does not directly state the data provenance (e.g., country of origin, retrospective/prospective). However, given that Uzinmedicare Co. is located in South Korea and it's a 510(k) submission to the FDA, the testing was likely conducted by or for the manufacturer. The tests are non-clinical (engineering/performance tests), not human clinical trials.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The tests performed are non-clinical engineering/performance tests, not studies requiring expert interpretation of ground truth in a clinical context (e.g., image reading).

4. Adjudication Method for the Test Set:

Not applicable. As these are non-clinical performance tests, there's no "adjudication method" in the sense of resolving conflicting expert opinions. The tests would likely involve measuring physical parameters against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The study is a non-clinical evaluation of a breast pump, not an AI-assisted diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:

Not applicable. This is a physical medical device (breast pump), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be established specifications and physical measurements, rather than clinical outcomes or expert consensus. For example, a vacuum test would measure the actual vacuum generated and compare it to the specified range (50-270 mmHg).

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this device.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K181784

Device Name Spectra S3 Plus Breast Pump

Indications for Use (Describe)

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)

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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: 82-31-739-5271 Email: shahn@uzinmedical.co.kr

SECONDARY CONTACT PERSON:

Heidi Humphries, RN, BSN, IBCLC Spectra Baby USA 6851 SW 21ST Court, Suite 1 Davie, FL 33317 Telephone: 954-471-4429 E-mail: hprn@aol.com

DEVICE:

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

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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 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.

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	Spectra S1 Plus Breast PumpPredicate Device (K150476)	Spectra S3 Plus Breast Pump
PatientPopulation	Breastfeeding women	Breastfeeding women
Indicationsfor Use	The Spectra S1 Plus is a single-user powered breast pumpintended to express and collectmilk from the breasts of lactatingwomen.	The Spectra S3 Plus Breast Pumpis a powered breast pump to beused by lactating women toexpress and collect milk from theirbreast. The Spectra S3 Plus BreastPump is intended for multipleusers in a hospital setting. It isalso intended for home use by asingle user.
Use Type	Single user	Multi-user and single user
Environmentof Use	Home	Hospital, Home
User Interface	LCD display, buttons, night light	LCD display, buttons, night light
Modes ofOperation	Massage, Expression	Massage, Expression
Single/DoublePumping	Single or Double	Single or Double
Accessories	Breast shield set, includesflange (28 mm) backflow protector valve tubing 12V AC Power adapterBottle Set (bottle, nipple, cap,disk, cover)	Breast shield set, includesflange (size 20, 24, 28 and 32 mm) backflow protector valve tubing 12V AC Power adapterBottle Set (bottle, nipple, cap,disk, cover)
Pump Type	Diaphragm	Diaphragm
SuctionLevels	12 Levels	12 Levels
SuctionStrength	$50 (\pm 50) $ mmHg to 270 (-50mmHg) (maximum 270 mmHg)	$50 (\pm 50) $ mmHg to 270 (-50mmHg) (maximum 270 mmHg)
	Spectra S1 Plus Breast PumpPredicate Device (K150476)	Spectra S3 Plus Breast Pump
Cycle Speed	38-70 cycles/min (adjustable)	38-70 cycles/min (adjustable)
Power Supply(ConventionalOutlet)	AC/DC wall converterInput 100V – 240AC, 50/60Hz,600mAOutput: 12V, 2A	AC/DC wall converterInput 100V – 240AC, 50/60Hz,600mAOutput: 12V, 2A
Power Supply(Battery)	Rechargeable Lithium Ion Battery11.1V 2000mAh Li-Polymer	Rechargeable Lithium Ion Battery11.1V 2000mAh Li-Polymer
Back FlowProtection	Yes, provided by siliconemembrane backflow protector	Yes, provided by siliconemembrane backflow protector
Software	Yes	Yes

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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

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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.

Regulation Number and Section

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).