(16 days)
Not Found
No
The description mentions a programmable microcontroller and stored pumping programs on cards, which indicates pre-programmed logic, not AI/ML. There is no mention of learning, adaptation, or data-driven decision making.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used to express breast milk, which is a physiological process, not a medical condition.
No
The device is a breast pump used for expressing and collecting milk, not for diagnosing a medical condition.
No
The device description explicitly details hardware components such as a DC motor, diaphragm pumps, a control knob, and pumping cards, indicating it is a physical device with integrated software control, not a software-only medical device.
Based on the provided information, the Symphony breast pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breast." This is a physical process of extracting a bodily fluid, not a diagnostic test performed on a sample of that fluid to gain information about a person's health or condition.
- Device Description: The description focuses on the mechanical aspects of creating suction to extract milk. There is no mention of analyzing the milk or using it for diagnostic purposes.
- Lack of Diagnostic Elements: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic information.
- Anatomical Site: The device interacts with the breast, which is the source of the milk, not a sample of the milk itself being analyzed.
IVD devices are typically used to examine specimens such as blood, urine, tissue, or other body fluids in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Symphony breast pump's function is purely for the physical collection of breast milk.
N/A
Intended Use / Indications for Use
The Symphony Powered Breast Pump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus identical to the predicate devices.
The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.
Product codes
85 HGX
Device Description
The Symphony Powered Breast Pump is intended to express the mother's milk of a lactating woman. The pumping action is employed to drive both diaphragm pumps, one for each breast or for both breasts at the same time. A DC motor drives the pumps to create the negative pressure (suction) required to extract the breast milk. Because the motor is controlled by a programmable microcontroller, the mother can potentially select from a number of pumping (suction) programs. The pumping programs are stored on separate pumping cards, which are inserted into the Breast Pump, prior to operating the device. The card is similar in size to a credit card.
The Symphony Powered Breast Pump employs a control knob, for the user to adjust the applied vacuum. The breast pump is capable of providing vacuum levels from 0 to 250 mmHg, constant of variable. Configured with a pumping rate of 40-120 cycles per minute, the breast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles.
All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.
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
lactating women
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KO20518
MAR
7 2002 MAR
Medela Inc., 1101 Corporate Drive, McHenry, IL 60050 Applicant: Marcel Felber, Tel (815) 363 1166 ext. 423; Fax (815) 363 1246 Contact Person: marcel.felber@medelainc.com 510(k) Submission for Medela® Symphony® Breastpump
Medela Powered Breast Pump Symphony®
1. Sponsor's Name, Address and Contact Person:
Sponsor: Medela Inc. 1101, Corporate Drive McHenry, IL 60050 (815) 363 1166 ext. 423 Ph: (815) 363 0460 Fax:
Contact Person: Marcel Felber Vice President Quality Management
Correspondent: Medela AG Medical Equipment Laettichstrasse 4b 6341 Baar Switzerland +41 41 769 52 28 Ph: Fax: +41 41 769 51 01
Contact Person Wemer Frei Manager Regulatory Affairs
Date Summary Prepared: October 31st, 2001
2. Name of Device:
Medela® Symphony® Powered Breast Pump Trade Name: Powered Breast Pump Common Name: Classification Name: Powered Breast Pump (Classified Class II, per 21 CFR section 884.5160).
3. Name of Predicate Device(s):
- Medela® Classic™ Breast Pump, by Medela Inc., K801862 .
- Egnell Elite Breast Pump, by Ameda Medizintechnik AG (Hollister Inc.), . K950531
1
Medela Inc., 1101 Corporate Drive, McHenry, IL 60050 Applicant: Marcel Felber, Tel (815) 363 1166 ext. 423; Fax (815) 363 1246 Contact Person: marcel.felber@medelainc.com 510(k) Submission for Medela® Symphony® Breastpump
4. Description of Device:
The Symphony Powered Breast Pump is intended to express the mother's milk of a The Symphony T owned Broad. The performed on one breast or on both breasts at lacialing woman. THE pamping vanloyed to drive both diaphragm pumps, one for the Same time. A B O motor gm pumps create the negative pressure (suction), required to extract the breast milk. Because the motor is controlled by a required to extract the broad. The mother can potentially select from a number of programmable microcontroller, the micher sumping programs are stored on separate pumping (Suction) programs. The Tents into the Breast Pump, prior to operating the device. The card is similar in size to a credit card.
The Symphony Powered Breast Pump employs a control knob, for the user to adjust The Symphony T owned Broad. Famp Chip Ship Ship Ship Shown bevels from C the applied vacuum. The breast pump is capable of providing vacuum levels from 0 constant of variable: 710 broad. Polo cycles per minute. Configured with a to 2001.11.11 Tig, Mill oyeast pump will provide a "Stimulation" mode of fast cycles along with an "Expression" mode of slower cycles.
All materials with milk contact or components with human breast contact are manufactured from materials that meet the appropriate FDA and international regulations concerning food contact and/or biocompatibility.
5. Intended Use of the Device:
The Symphony Powered Breast Pump is intended to express and collect the mother's milk from the breasts of a lactating woman, thus identical to the predicate devices.
6. Summary of Technological Characteristics:
The technology of the Symphony® powered breast pump is identical to the predicate The lectinology of the Oymphony® perceive areast particle would raise new aspects regarding safety and effektiveness.
7. Conclusion:
Based upon the information presented above, it is concluded that the proposed Dased upon the information is safe and effective for the intended use, and is substantially equivalent to the predicate devices.
2
Image /page/2/Picture/1 description: The image is a black and white circular seal. The seal contains a symbol in the center that resembles three curved lines stacked on top of each other. The text "HEALTH & HUMAN SERVICES" is arranged around the top half of the circle, and the text "U.S. DEPARTMENT OF" is arranged around the bottom half of the circle.
Food and Drug Administration 00 Corporate Boulevard Rockville MD 20850
7 2002 MAR
Medela, Inc. % Mr. Mark Job Program Manager TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891
Re: K020518
Trade/Device Name: Medela Symphony Electrically Powered Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: 85 HGX Dated: February 12, 2002 Received: February 19, 2002
Dear Mr. Job:
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.
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); 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.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 _ of 1
510(k) Number (if known): KC20516
Device Name: Symphony
Indications For Use:
The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
(Division Sign-Off) o
Division of Reproductive,
and Radiological Devices
510(k) Number K020518
(Optional Format 3-10-98)
Over-the-Counter Use