The Luxmatic 12-15 ISC Portable Electric Breast Pump (suction device with a compressor unit) contains a diaphragm-type pump with a vacuum regulator (between 150mm Hg and 220mm Hg) which includes a soft silicone tube and plastic tubing. An accessory kit includes overflow safety bottles, plastic breast shields and a collection cup. The device is battery and line-powered for 12V DC by a transformer or utilizes a 12V battery pack. The device is controlled by an electric sensor with intermittent suction at approximately 30-45 cycles. The overflow bottle contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the overflow. The pump can be used with Single Breast Pump Kit #281100 or Double Breast Pump Kit #281102. Dimensions are 7 X 12 X 7 inches and the weight is 4.5 lbs. Suction is controlled by the pump automatically. It will automatically be released when the adjusted vacuum is reached. An electronic sensor is built-in for automatic motor shut off: If milk flows into the overflow bottle, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. A bacterial filter may be used between the overflow bottle and the pump to prevent cross infection when more than one patient is using the pump. Bacterial filters should be changed regularly.

AI/ML Overview

Here's an analysis of the provided information regarding acceptance criteria and studies for the Luxmatic 12-15 ISC Portable Electric Breast Pump:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific quantitative acceptance criteria in the traditional sense of a performance study. However, we can infer some "acceptance criteria" based on the comparisons made and the nature of the non-clinical tests.

Acceptance Criteria (Inferred)	Reported Device Performance (Luxmatic 12-15 ISC)	Original Predicate Device Performance (White River K#850705)
Functional Equivalence
Pump Type: Diaphragm	Diaphragm	Same (Diaphragm)
Vacuum Control Cycle	Yes	Same (Yes)
Overflow Bottle	Yes	Same (Yes)
Overflow Shutoff	Yes	Same (Yes)
Collection Bottles	Yes	Same (Yes)
Single Patient Use	Yes	Yes
Indications for Use	Same (to express milk from the breast)	Same (to express milk from the breast)
Performance Parameters
Adjustable Suction Range	150-220 mm Hg	Not Available (implies the Luxmatic offers a specific range which is a differentiator but still acceptable for safe and effective use)
Vacuum Gauge	Yes	Same (Yes)
Bacteria Filter	Yes	Not Available (implies an added safety feature)
Safety and Compliance
Electrical Isolation	Met IEC-601-1-2 (1993)	Not explicitly stated, but assumed compliant with relevant standards for a marketed device.
Electrical/Mechanical/Environmental Performance	Met FDA November 1993 Draft "Reviewer Guidance" & TÜV GS Germany requirements	Not explicitly stated, but assumed compliant with relevant standards.
Patient-contacting Material (Skin & Milk) Approval	Approved for food contact per 21 CFR Parts 176, 177, 178	Not explicitly stated, but assumed compliant.
No design characteristics violating Reviewer Guidance or safety hazards	Confirmed no violations/hazards during testing.	Not explicitly stated, but assumed compliant.
Weight (Comparative, not absolute 'acceptance')	4.5 lbs.	10 lbs. (Luxmatic is significantly lighter, which is a design difference but not a safety/effectiveness issue)

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

Sample Size: The document states that "The breastpumps were manufactured in series production and checked with TÜV GS approved samples." It doesn't specify a numerical sample size for the non-clinical tests, but it implies that production samples were used for testing. It doesn't mention specific unit numbers.
Data Provenance: The testing was conducted internally by KaWeCo GmbH in Germany, or by a testing body contracted by them, to meet FDA and German (TÜV GS) standards. The report itself is a "Summary of 510(k) safety and effectiveness information," indicating it's a submission to the FDA. The nature of the tests (electrical, mechanical, material compatibility) means they are inherently prospective (testing the device before market release).

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

Not Applicable. This device is a medical device (breast pump) and the assessment of its safety and effectiveness relies on engineering and materials testing, not diagnostic accuracy requiring expert interpretation of medical images or symptoms. Therefore, the concept of "ground truth" established by medical experts for a test set is not relevant in this context. The "ground truth" here is compliance with technical standards and material regulations.

4. Adjudication Method for the Test Set:

Not Applicable. As explained above, the assessment is based on objective measurements against engineering and material standards, not subjective expert judgment that would require adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret cases (e.g., medical images) and their performance with and without AI assistance is compared. This breast pump is not a diagnostic device, so an MRMC study was not performed. The "comparison" is not about reader improvement but about device features and safety/effectiveness equivalence to a predicate.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not Applicable. This is not a software algorithm or AI device. The device itself (the breast pump) is the "standalone" entity whose performance is being evaluated against safety and effectiveness standards without a "human-in-the-loop" component in the sense of a diagnostic interpretation task.

7. Type of Ground Truth Used:

The "ground truth" for this device's safety and effectiveness assessment is based on:
- Engineering Standards Compliance: Meeting requirements outlined in IEC-601-1-2 (1993) and IEC 601-1-1-2 (1993), as well as TÜV GS Germany requirements and the FDA's November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions."
- Material Compatibility Regulations: Compliance with 21 CFR Parts 176, 177, and 178 for food-contacting materials.
- Functional Equivalence: Demonstrating that the device performs its intended function (expressing milk) in a similar manner to the predicate device, despite some design differences.

8. Sample Size for the Training Set:

Not Applicable. This is not a machine learning or AI device that requires a training set.

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

Not Applicable. As no training set was used, this question is irrelevant.

Summary

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EXHIBIT #1 Page 1 of 4 K971543

SFD 18 1997

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is:_K971543

1. Submitter's Identification:

KaWeCo GmbH Gerlinger Str. 36-38 71254, Ditzingen Germany

Date Summary Prepared: April 24, 1997

2. Name of the Device:

Luxmatic 12-15 ISC Portable Electric Breast Pump

Predicate Device Information: 3.

K#850705, White River Portable Electric Breast Pump, White River, Division of Natural Technologies, Inc.

4. Device Description:

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EXHIBIT #1 Page 2 of 4 2971543

The overflow bottle contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the overflow. The pump can be used with Single Breast Pump Kit #281100 or Double Breast Pump Kit #281102. Dimensions are 7 X 12 X 7 inches and the weight is 4.5 lbs.

Suction is controlled by the pump automatically. It will automatically be released when the adjusted vacuum is reached. An electronic sensor is built-in for automatic motor shut off: If milk flows into the overflow bottle, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. A bacterial filter may be used between the overflow bottle and the pump to prevent cross infection when more than one patient is using the pump. Bacterial filters should be changed regularly.

5. Intended Use:

ﺳ

The intended use of this electrically powered (diaphragm-type) suction device is to express milk from the breast.

6. Comparison to Predicate Devices:

Table of Comparison to Legally Marketed Device:

The following is a comparison chart outlining differences and similarities between the Luxmatic 12-15 ISC Portable Electric Breast Pump and the White River Portable Electric Breast Pumps:

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EXHIBIT #1

Page 3 of 4

K971543

PARAMETER	LUXMATIC	WHITE RIVER(K#850705)
Pump Type	Diaphragm	Same
Vacuum Control Cycle	Yes	Same
Adjustable Suction Range	150-220 mm Hg	Not Available
Vacuum Gauge	Yes	Same
Bacteria Filter	Yes	Not Available
Overflow Bottle	Yes	Same
Overflow Shutoff	Yes	Same
Collection Bottles	Yes	Same
Single Patient Use	Yes	Yes
Indications for Use	Same	Same
Weight	4.5 lbs.	10 lbs.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Testing information demonstrating safety and effectiveness of the Luxmatic 12a) 15 ISC Portable Electric Breast Pump in the intended environment of use is supported by testing that was conducted in accordance with the FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND, which outlined Electrical, Mechanical and Environmental Performance Requirements.

Testing was conducted on the Luxmatic 12-15 ISC Portable Electric Breast Pump per IEC-601-1-2 (1993) (electrical isolation) and IEC 601-1-1-2 (1993). Testing met TÜV GS Germany requirements. The breastpumps were manufactured in series production and checked with TÜV GS approved

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EXHIBIT #1 Page 4 of 4

K971543

samples.

None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards.

b) Patient-contacting material includes both skin contacted material (breastcups) and milk contacting materials. 21 CFR Parts 176, 177 and 178 were reviewed in order to ascertain materials approved for food contact. Materials are approved for food contact.

8. Discussion of Clinical Tests Performed:

Non-Applicable

9. Conclusions:

The Luxmatic 12-15 ISC Portable Electric Breast Pump has the same intended use, similar design and technology as the White River Portable Electric Breast Pump. As our comparison chart indicates, as well as our testing data, the Luxmatic 12-15 ISC Portable Electric Breast Pump raises no new questions of safety or effectiveness. Thus, when compared to the predicate device, the Luxmatic 12-15 ISC Portable Electric Breast Pump does not incorporate any significant changes in intended use, method of operation, material or design that could affect safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

KaWe Co. GmbH c/o Ms. Susan Goldstein-Falk MDI Consultants. Inc. 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

18 1997

Re: K971543 Luxmatic 12-15 ISC Portable Electric Breast Pump Dated: July 31, 1997 Received: August 11, 1997

Regulatory class: II 21 CFR §884.5760/Product code: 85 HGX

Dear Ms. Goldstein-Falk:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the intenstions for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note; this response to your premarket notification does not affect any obligation vou might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807,97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

W.iliau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ЕХНІВІТ В Page_1_ of 1

16971543 510(k) Number (if known):_

Device Name: Luxmatic 12-15 ISC Portable Electric Breast Pump

Indications For Use:

The intended use of this electrically powered (diaphragm-type) suction device is to express milk from the breast.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Roler R. Sathing/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K971543

Prescription Use_^ (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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).