(143 days)
K#850705
Not Found
No
The device description details standard electrical and mechanical components with basic sensor-based automation, not AI/ML. There is no mention of AI, ML, or related concepts in the summary.
Yes
A breast pump is often considered a therapeutic device because it aids in the physiological process of milk expression, which can be crucial for the health of both the mother (e.g., preventing engorgement, maintaining lactation for premature infants) and the infant (providing necessary nutrition).
No
The intended use of the device is to express milk from the breast, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines numerous hardware components including a diaphragm-type pump, vacuum regulator, tubing, breast shields, collection cup, battery/line power, electric sensor, optical sensor, and motor. The performance studies also focus on electrical, mechanical, and environmental performance requirements of the physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express milk from the breast." This is a physical process performed on the human body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical pump designed to apply suction to the breast. It does not involve analyzing any biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition
- Using reagents or calibrators
This device is a medical device, specifically a breast pump, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The intended use of this electrically powered (diaphragm-type) suction device is to express milk from the breast.
Product codes (comma separated list FDA assigned to the subject device)
85 HGX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing information demonstrating safety and effectiveness of the Luxmatic 12-15 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 samples. None of the testing demonstrated any design characteristics that violated the requirements of the Reviewer Guidance or resulted in any safety hazards.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#850705
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
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.
1
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:
2
EXHIBIT #1
Page 3 of 4
| 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
3
EXHIBIT #1 Page 4 of 4
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.
4
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
5
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)
OR
Over-The-Counter Use
(Optional Format 1-2-96)