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.

AI/ML Overview

The provided document is a 510(k) summary for the UZINMEDICARE CO. Spectra Series Breast Pump. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving the device meets those criteria in the way a clinical trial for a diagnostic algorithm would.

Therefore, many of the requested sections about acceptance criteria and study details (like sample size, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not explicitly provided in this type of regulatory submission for a breast pump.

Here's the information that can be extracted and a clear indication of what is not present:

Acceptance Criteria and Device Performance

The "acceptance criteria" for this device, in the context of a 510(k) submission for a breast pump, are primarily related to its functional specifications and ensuring it performs similarly to legally marketed predicate devices without raising new questions of safety or effectiveness. The comparison chart among devices serves as a de facto demonstration of performance against these implied criteria.

Table of Acceptance Criteria (Implied by Predicate Device Comparison) and Reported Device Performance:

Feature/Acceptance Criteria (Implied)	Predicate Device A (Playtex Embrace Petite)	Predicate Device B (Medela Lactina Plus)	Predicate Device C (Ameda Purely Yours)	Spectra Series Breast Pump (Reported Performance)
Intended Use	To Express Milk	To Express Milk	To Express Milk	To Express Milk
Power Source	DC Power Supply	AC Power Supply	DC Power Supply or 6 AA Batteries	AC Power Supply
Pump Type	Piston	Piston	Piston	Piston
Single or Double Pumping	Both	Both	Both	Both
Adjustable Suction Levels	Yes	Yes	Yes	Yes
Adjustable Cycle Speed	No	No	Yes	No
Overflow Protection	Yes	No	Yes	Yes
Highest Vacuum Setting (mmHg)	214	240	163	400 Less than
Lowest Vacuum Setting (mmHg)	72	100	21	150
Range of Cycle Speeds (Cycles/min)	45	66-41	67-29	46-47
Weight (Kg)	-	2.4	-	2.1

Note: The reported performance for the Spectra Series Breast Pump is presented against specifications of predicate devices rather than against explicit, quantified acceptance criteria like sensitivity/specificity for a diagnostic device. The "Highest Vacuum Setting" for the Spectra is stated as "400 Less than," which seems to be a typo and likely means a maximum of 400 mmHg or less than 400 mmHg. Given the other predicate values, it's probably intended to mean its maximum vacuum is less than 400 mmHg.

Study Details

Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. This document describes a 510(k) premarket notification, which relies on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing, rather than a clinical study with a "test set" of patients in the context of, for example, a diagnostic algorithm. The testing mentioned is "non-clinical."
- Data Provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. No human ground truth establishment for a test set is described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No human adjudication process is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable / Not Provided. This device is a breast pump, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance comparisons are irrelevant in this context.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided. This device is a mechanical breast pump. "Standalone performance" in the context of an algorithm is not relevant. The device operates independently to express milk.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided. The "truth" for a breast pump is its functional operation (e.g., vacuum levels, cycle speed, safety features) to express milk, rather than a diagnostic ground truth like pathology. The "ground truth" here is adherence to engineering specifications and safety standards, demonstrated through non-clinical testing.
The sample size for the training set:
- Not Applicable / Not Provided. There is no "training set" in the context of an AI/machine learning algorithm for this mechanical device.
How the ground truth for the training set was established:
- Not Applicable / Not Provided. No training set or associated ground truth establishment is relevant for this mechanical device.

Summary regarding the study:

The document states under "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."

This implies that standard non-clinical performance and safety testing (e.g., electrical safety, electromagnetic compatibility, material biocompatibility, vacuum accuracy, durability, and functional testing to ensure it meets its specifications and performs similarly to predicate devices) was performed. However, the document does not provide details of these specific tests, their methodologies, or the precise results beyond the comparative table. The study is a "non-clinical" comprehensive device evaluation against engineering and safety standards, not a human reader or AI performance study.

Summary

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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 : +82-31-322-0132

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.: +82-10- 5069-7155

Fax No .: +82- 31- 322- 4292

E-Mail: choiyyjj@yahoo.com

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: wwjdksn@hotmail.com

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.

	UzinmedicareSpectra Series	PlaytexEmbrace PetiteBreast Pump	Medela LactinaPlus	Ameda PurelyYours
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 PowerSupply	AC PowerSupply	DC PowerSupply or 6 AABatteries
Pump Type	Piston	Piston	Piston	Piston
Single or DoublePumping	Both	Both	Both	Both
Adjustable SuctionLevels	Yes	Yes	Yes	Yes
Adjustable CycleSpeed	No	No	No	Yes
Overflow Protection	Yes	Yes	No	Yes
Highest VacuumSetting(mmHg)	400 Less than	214	240	163
Lowest VacuumSetting(mmHg)	150	72	100	21
Range of CycleSpeeds(Cycles/min)	46-47	45	66-41	67-29
Weight (Kg)	2.1	-	2.4	-

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7. Description of Device

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.

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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Page 2

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 (800) 638-2041 or (301) 796-7100 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.82-31-322-0132/Fax.82-31-322-4292

Image /page/5/Picture/2 description: The image shows a handwritten text string. The string appears to be a code or identifier, consisting of a combination of letters and numbers. The text reads 'K09 3/45', with a slightly slanted orientation. The handwriting is clear and legible, with distinct strokes forming each character.

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

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).