(86 days)
The Lactaline Personal Powered Breast Pumps (Premier/Expresse) are intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
The Expresse and Premier powered breast pumps are intended to express the mother's milk of a nursing woman. The pumping can be performed on one breast or both breasts at the same time. A control knob adjusts the suction strength (vacuum) to one of 8 settings between <100 and 360 mbar. Another control knob adjusts the suction rhythm (cycle) to one of 4 settings from 30 to 60 cycles per minute. The difference between the Premier and Expresse are the special bottle holders on the Expresse for using Freezer bags. All other features are substantially equivalent (Software, size, suction capacity, control knobs, weight, noise level and power supply.)
The provided document is a 510(k) premarket notification for the Ameda Egnell Powered Breast Pumps (Expresse and Premier). This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive standalone testing.
Therefore, much of the requested information (acceptance criteria, specific study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, specific ground truth methods for training/testing sets) is not explicitly available within the provided text.
However, based on the information provided, I can infer what constitutes "acceptance" for this regulatory submission and extract the performance characteristics presented for comparison.
Here's a breakdown of what can be inferred and what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k), "acceptance criteria" are generally met when the proposed device demonstrates substantial equivalence to legally marketed predicate devices, particularly concerning intended use, technological characteristics, and safety/effectiveness. The table provided is a comparison of technological characteristics to establish this equivalence, rather than a list of "acceptance criteria" in the traditional sense of performance targets.
| Characteristic | Acceptance (Substantial Equivalence to Predicate) | Ameda Egnell Expresse/Premier Performance (Proposed Devices) |
|---|---|---|
| Intended Use | As described in 21 CFR 884.5160 | As described in 21 CFR 884.5160 |
| Suction Levels (Single) | Comparable to predicate devices (e.g., 0-360 mbar, 80-240 mmHg) | <100-360 mbar |
| Suction Levels (Double) | Comparable to predicate devices (e.g., 0-360 mbar) | <100-265 mbar |
| Suction Cycles | Comparable to predicate devices (e.g., 30-60 cycles/minute) | 30-60 cycles per minute |
| Power Supply | Multiple options (rechargeable, alkaline, AC, 12V adapter) | Rechargeable NiCd, 6 AA alkaline, AC adapter, 12V adapter |
| **Cycling/Suction Control ** | Comparable to predicate devices (Microprocessor or Mechanical) | Microprocessor |
| Breast Pumping Option | Single or double pumping | Single or double pumping |
| Weight | Comparable to predicate devices (e.g., 5-7 pounds) | 1.1 pounds |
Note: The "Acceptance" column here reflects the range or type of characteristics seen in the predicate devices, which the proposed devices aim to match or fall within, thereby demonstrating substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided in the document. This is a 510(k) submission based on technological characteristics and comparison to predicate devices, not typically involving a test set of data from human subjects for performance evaluation like an AI/medical imaging device. Device performance is inferred from design and comparison.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable/Not provided. The ground truth for this submission is regulatory compliance and established performance of predicate devices. There wouldn't be a "ground truth" derived from expert review of output in the way one would for an AI performance study.
4. Adjudication Method
Not applicable/Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done or reported in this document. This submission does not involve AI assistance for human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a mechanical/electronic medical device, not an algorithm. Performance is demonstrated through technical specifications and comparison, not standalone algorithm performance testing.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the established safety and effectiveness of the identified predicate devices as determined by prior FDA clearances and regulatory standards (e.g., 21 CFR 884.5160 for intended use). The applicant argues that their device's technological characteristics are sufficiently similar to these predicates.
8. The Sample Size for the Training Set
Not applicable/Not provided. Training sets are relevant for AI/machine learning models, which this device is not.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided.
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DFC | 1997
Image /page/0/Picture/1 description: The image shows the word "Hollister" in a serif font next to a geometric symbol. The symbol is a stylized cross or asterisk shape, composed of several short, thick lines arranged symmetrically around a central void. The text and symbol are both black and appear to be slightly distressed or textured, giving them a vintage or worn look.
Hollister Incorporated 2009 Hollister Drive Libertyville, Illinois 60048-3781 1102
97350
Ameda Egnell Powered Breast Pumps Expresse and Premier
510(k) Summary
1. Sponsor's name, Address and Contact Person
- Contact Person Sponsor Joseph S. Tokarz AMEDA AG Manager, Regulatory Affairs Medizin-Technik Hollister Incorporated Bösch 106 2000 Hollister Drive CH-6331 Hünenberg Libertyville, IL 60048 Switzerland (847)680-2849 Ph: (847)918-3860 Fax:
Date Summary Prepared - September 12, 1997
2. Name of Device:
Expresse and Premier Powered Breast Pumps
3. Name of Predicate Device(s)
- · The Medela Lactina Breast Pump by Medela, K875300, April 6, 1988
- · The Medela Pump In Style Breast Pump (not known)
- · Egnell Elite Breast Pump by Ameda/Egnell, K950531, September 22, 1995
4. Description of Device
The Expresse and Premier powered breast pumps are intended to express the mother's milk of a nursing woman. The pumping can be performed on one breast or both breasts at the same time. A control knob adjusts the suction strength (vacuum) to one of 8 settings between <100 and 360 mbar. Another control knob adjusts the suction rhythm (cycle) to one of 4 settings from 30 to 60 cycles per minute.
The difference between the Premier and Expresse are the special bottle holders on the Expresse for using Freezer bags. All other features are substantially equivalent (Software, size, suction capacity, control knobs, weight, noise level and power supply.)
5. Statement of Intended Use
The Battery Breast Pumps, Expresse and Premier, are intended to express and collect the mother's milk from the breasts of a nursing woman, for the purpose of feeding the collected milk to a baby.
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Image /page/1/Picture/0 description: The image shows the Hollister logo. On the left is a black geometric shape that resembles a snowflake or a stylized flower. To the right of the shape is the word "Hollister" in a serif font.
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P2072
Ameda Egnell Powered Breast Pumps Expresse and Premier
6. Statement of Technological Characteristics of the Device
The Expresse and Premier Powered Breast Pumps are substantially equivalent to other powered breast pumps that are in commercial distribution. A chart showing the similarities and differences of the proposed powered breast pumps and the predicate powered breast pumps follows:
| Proposed devices | Predicate Devices | ||||
|---|---|---|---|---|---|
| Characteristics | Expresse | Premier | Egnell EliteK950531 | Medela LactinaSelect K875300 | Medela Pump inStyle |
| Intended Use | as described in 21CFR 884.5160 | as described in 21CFR 884.5160 | as described in 21CFR 884.5160 | as described in 21CFR 884.5160 | as described in 21CFR 884.5160 |
| Suction LevelsSingle pumping | <100-360 mbar | <100-360 mbar | 0-360 mbar | 80-240 mmHg | 80-240 mm Hg |
| Double Pumping | <100-265 mbar | <100-265 mbar | 0-360 mbar | ||
| Suction Cycles | 30-60 cycles perminute | 30-60 cycles perminute | 30-60 cycles perminute | 42-60 cycles perminute | 48 per minute |
| Power Supply | a) rechargeableNiCd batteriesb) 6 AA alkalinebatteries | a) rechargeableNiCd batteriesb) 6 AA alkalinebatteries | a) rechargeableNiCd battery | a) rechargeablebattery | a) rechargeablebattery |
| c)AC adapterd) 12 V adapterfor use in a motorvehicle | c)AC adapterd) 12 V adapterfor use in a motorvehicle | b) AC power cordc) 12 V adapterfor use in motorvehicle | b) AC adapterc) 12 V adapterfor use in a motorvehicle | b) AC adapterc) 12 V adapterfor use in a motorvehicle | |
| Cycling/Suctioncontrol mechanism | Microprocessor | Microprocessor | Microprocessor | Mechanicalcycling suctionregulator | Mechanicalcycling suctionregulator |
| Breast pumpingoption | Single or doublepumping | Single or doublepumping | Single or doublepumping | Single or doublepumping | Single or doublepumping |
| Weight | 1.1 pounds | 1.1 pounds | 6.5 pounds | 5 pounds | 7 pounds |
7. Conclusion
Based on the information presented above it is concluded that the proposed Expresse and Premier Powered Breast Pumps are safe and effective for their intended use and are substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Joseph S. Tokarz Manager, Regulatory Affairs Hollister, Inc. 2000 Hollister Drive Libertyville, Illinois 60048-3781 Re: K973501
Ameda Egnell Powered Breast Pumps, Lactaline Personal (Expresse and Premier) Dated: September 12, 1997 Received: September 16, 1997 Regulatory Class: II 21 CFR 8884.5160/Product Code: 85 HGX
DEC I I 1997
Dear Mr. Tokarz:
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 indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class III (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 Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Pailure 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 submission does not affect any obligation you 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 predication 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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.Liau 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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Ameda Egnell Powered Breast Pumps, Lactaline Personal (Premier and Expresse)
b. Statement of Intended Use
510(k) Number (if Known): Device Name:
K973501 Ameda Egnell Powered Breast Pumps, Lactaline Personal (Premier/Expresse)
Intended Use:
The Lactaline Personal Powered Breast Pumps (Premier/Expresse) are intended to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter-Use
Robert D. Satterfield/
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number _
Page 5
§ 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).