(141 days)
K020518 Medela Symphony Breast Pump Model 024
Not Found
No
The description focuses on standard breast pump functionality, vacuum control, and programmed cycles. There is no mention of AI, ML, or any adaptive or learning capabilities. The software is described as "moderate" level of concern, which is typical for devices with basic control logic, not complex AI/ML.
No
A breast pump is used to express and collect milk, which is not considered a therapeutic function. Therapeutic devices are typically used for the treatment, prevention, or diagnosis of diseases, or to restore, correct, or modify physiological functions.
No
The device description clearly states that the Symphony breast pump is "to be used by lactating women to express and collect milk from their breast." There is no indication or mention of any diagnostic function.
No
The device description explicitly details hardware components like a control knob, motor, and the ability to provide vacuum levels, indicating it is a physical device with integrated software, not a software-only device. The performance studies also include testing of hardware aspects like electrical safety, electromagnetic compatibility, and motor lifetime.
Based on the provided information, the Symphony breast pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breast." This is a physical process involving the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details the mechanical function of the pump (vacuum levels, cycles, single/double pumping) and its design for multi-user use. It does not mention any analysis of 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.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
- Measuring biomarkers
The Symphony breast pump is a medical device, but it falls under a different category than IVDs. It is a device used to physically interact with the body for a specific purpose (milk expression).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Symphony breast pump is intended to be used by lactating women to express and collect milk from their breasts. The pumping can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). The Symphony breast pump is a multi-user breast pump and therefore, designed for a safe and hygienic use by different mothers.
The Symphony breast pump employs a control knob for the user to adjust the applied vacuum. The suction patterns are programmed with either constant or variable cycles (pump speed). The Symphony breast pump is capable of providing vacuum levels from -50 to -250 mmHg with cycling rates up to 120 cycles per minute.
The Symphony® breast pump provides the following user features:
- Belt-driven vacuum pump design, for quiet operation.
- Portable or trolley-mounted transport/operation options.
- LCD display, for user assistance/device status.
- Control knob, for user adjustment of vacuum level/pump speed.
- 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm:
- Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing
- Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
- Symphony program card with the initiation program (Preemie+) software. The Preemie+ program contains stimulation and expression phases with breast pump suction patterns which assist pump users in the initiation of milk production. The Preemie+ program mimics the irregular sucking pattern of healthy term infants right after birth.
- Symphony program card with the "Standard" pumping program software. The Standard program contains stimulation and expression phases with breast pump suction patterns which assist users in coming to volume, and/or maintenance of lactation. The Standard program imitates a breastfeeding baby during established lactation.
- "Let-down" control button to change between stimulation phase and expression phase.
- Option of either single or double breast pumping.
- Disposable protective membrane, designed to isolate the pump mechanism from the breast milk collection apparatus (prevent milk overflow into the pump). No vacuum can be created if the protective membrane is missing or damaged.
- User-friendly pump exterior, designed for ease of cleaning.
- A variety of accessories and breast pump kits.
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. Can be used in Hospital and Home environments.
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)
Performance testing at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications, which are identical to those of the predicate version of the Symphony pump. Tests were conducted over 20 minutes with the Standard 2.0 program card or 15 minutes with the Preemie+ program card to simulate a typical pumping session using size medium (M) breast shields. Tests began in stimulation mode and continued with expression mode after the first two minutes. There are two approved suppliers of the motor for the Symphony® breast pump. Testing of six pumps was completed with the Standard 2.0 program card, using three pumps with each motor type. One of each pump type was used for testing with the Preemie+ program card. Vacuum performance during normal use was first evaluated and demonstrated that, independent of the pump motor type, the specification for vacuum level and cycle rate is met. Additional test cases evaluated performance of the pump when running on battery, performance with varying input voltages and with the other size breast shields. Finally, testing of performance for single pumping was completed. Results demonstrated that independent of the pump motor type, the specification for battery operation time is met, that the specification for vacuum level and cycle rate is met in single pumping mode as well as with all power source and with varying input voltage. With different breast shield sizes, the specification for the maximum vacuum level is met.
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.
K020518 Medela Symphony Breast Pump Model 024
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
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing to the right. The symbol is composed of three curved lines that overlap each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 5, 2015
Medela AG % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324 S3649 County Road E Dousman, WI 53118
Re: K151632
Trade/Device Name: Symphony Breastpump, Symphony Reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery Version), Symphony Consignment, Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: October 2, 2015 Received: October 5 17, 2015
Dear Adrienne Lenz,
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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151632
Device Name
Symphony breast pump, Models: Symphony Preeme+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Symphony Preemie Consignment Pump, Symphony Plus Rental, Symphony Preemie+ Rental, Symphony Reconditioned
Indications for Use (Describe)
The Symphony breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(K) SUMMARY
MEDELA AG SYMPHONY BREAST PUMP
4
510(k) Summary
K151632
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: October 30, 2015
SUBMITTER:
Medela AG Lättichstrasse 4b 6341 Baar / Switzerland Phone +41 (0)41 769 51 51 Fax + 41 (0)41 769 51 00
PRIMARY CONTACT PERSON:
Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC T 262-290-0023
SECONDARY CONTACT PERSON:
Orlando Antunes Vice President Regulatory Affairs Medela AG
DEVICE:
TRADE NAME: Symphony breast pump, Models: Symphony Breastpump, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), Symphony Consignment, Symphony Preemie Consignment Pump, Symphony Rental, Symphony Plus Rental, Symphony Preemie+ Rental, Symphony Reconditioned
COMMON/USUAL NAME: Powered Breast Pump
DEVICE CLASS: Class II
CLASSIFICATION NAMES: 21 CFR 884.516022 Pump, Breast, Powered
PRODUCT CODE: HGX
5
PREDICATE DEVICE(S):
K020518 Medela Symphony Breast Pump Model 024
DEVICE DESCRIPTION:
The Symphony breast pump is intended to be used by lactating women to express and collect milk from their breasts. The pumping can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). The Symphony breast pump is a multi-user breast pump and therefore, designed for a safe and hygienic use by different mothers.
The Symphony breast pump employs a control knob for the user to adjust the applied vacuum. The suction patterns are programmed with either constant or variable cycles (pump speed). The Symphony breast pump is capable of providing vacuum levels from -50 to -250 mmHg with cycling rates up to 120 cycles per minute.
The Symphony® breast pump provides the following user features:
- Belt-driven vacuum pump design, for quiet operation.
- . Portable or trolley-mounted transport/operation options.
- LCD display, for user assistance/device status.
- Control knob, for user adjustment of vacuum level/pump speed.
- . 2-Phase Expression® Technology designed to mimic a baby's natural nursing rhythm:
- . Stimulation Phase (phase 1): Suction pattern with fast cycles and low vacuum to start milk flowing
- . Expression Phase (phase 2): Suction pattern with slower cycles and higher vacuum to express more milk gently and efficiently.
- Symphony program card with the initiation program (Preemie+) software. The Preemie+ program contains stimulation and expression phases with breast pump suction patterns which assist pump users in the initiation of milk production. The Preemie+ program mimics the irregular sucking pattern of healthy term infants right after birth.
- Symphony program card with the "Standard" pumping program software. The Standard program contains stimulation and expression phases with breast pump suction patterns which assist users in coming to volume, and/or maintenance of lactation. The Standard program imitates a breastfeeding baby during established lactation.
- "Let-down" control button to change between stimulation phase and expression phase.
- Option of either single or double breast pumping.
6
- Disposable protective membrane, designed to isolate the pump mechanism from the breast milk collection apparatus (prevent milk overflow into the pump). No vacuum can be created if the protective membrane is missing or damaged.
- User-friendly pump exterior, designed for ease of cleaning.
- A variety of accessories and breast pump kits.
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.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The Symphony breast pump has identical indications for use compared to the previously cleared version (K020518). A number of modifications have been made to the Symphony Breast Pump since the last 510(k) clearance (K020518). These are types of changes expected during years of production, including changes to meet new or modified standards and non-US regulations, manufacturing improvements to increase yield, improve stability and precision of components and prevent damage during use. Changes to the software have also been made, including the introduction of the Preemie+ initiation program.
The table below identifies key similarities and differences of the proposed Symphony breast pump to the legally marketed predicate version of this device (K020518).
| Symphony (Current Version) | Symphony (Predicate Version) | |
|---|---|---|
| K020518 | ||
| 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. | The Symphony breast pump is a | |
| powered breast pump to be used by | ||
| lactating women to express and collect | ||
| milk from their breast. | ||
| Environment of | ||
| Use | Hospital, Home | Hospital, Home |
| TABLE 5.1 COMPARISON OF SYMPHONY TO PREDICATE DEVICE | ||
|---|---|---|
| Symphony (Current Version) | Symphony (Predicate Version) | |
| K020518 | ||
| User Interface | Hardware interfaces | Hardware interfaces |
| User Control | State-dependent controls: | |
| On-Off membrane switch | ||
| Let-Down Button (membrane switch), | ||
| also used to select the Preemie+ | ||
| initiation program | ||
| Value-adjustment control: | ||
| Vacuum/Cycle-adjustment control | State-dependent controls: | |
| On-Off membrane switch | ||
| Let-Down Button (membrane switch) | ||
| Value-adjustment control: | ||
| Vacuum/Cycle-adjustment control | ||
| Visual Indicator | Liquid-crystal display | Liquid-crystal display |
| Single/Double | ||
| Pumping | Single and double pumping | Single and double pumping |
| Accessories | Breast shield Breast shield inserts Valve Membrane Tubing Bottles, with disks lids and caps Trolly Vehicle adapter Power cord Container Stand Cooler Colostrum and Collection Containers Pump and Save Bags | Breast shield Breast shield inserts Valve Membrane Tubing Bottles, with disks lids and caps Trolly Vehicle adapter Power cord |
| Cleaning | Breastpump/case - wipe with clean, damp cloth Tubing - wash or sanitize only if milk or condensation in tubing Breastpump kit and bottles - wash and sanitize | Tubing - wash or sanitize weekly or if milk or condensation in tubing Breastpump kit and bottles - wash and sanitize (home) or autoclave sterilization (hospital) |
| Specifications | ||
| Power Source | 100-240 Vac | 100-240 Vac |
| 50/60Hz | 50/60Hz | |
| 0.3A | 0.3A | |
| Symphony (Current Version) | Symphony (Predicate Version) | |
| K020518 | ||
| Batteries | 2 x 6V/1.2Ah | |
| Rechargeable Pb Batteries | 2 x 6V/1.2Ah | |
| Rechargeable Pb Batteries | ||
| Battery charge/discharge | Operation time: approx. 1 hour | |
| Charging time: approx.. 4 hours (80%) | ||
| approx.. 8 hours (100%) | Operation time: approx. 1 hour | |
| Charging time: approx.. 4 hours (80%) | ||
| approx.. 8 hours (100%) | ||
| Housing Material | Polyamide | PS coated |
| Vacuum aggregate type | Diaphragm pump | |
| Two diaphragms - for left and right breast | ||
| Linear movement by driving bars | Diaphragm pump | |
| Two diaphragms - for left and right breast | ||
| Linear movement by driving bars | ||
| Vacuum Regulation type | Electronic measuring of the displacement of the membranes which corresponds to the generated vacuum. | Electronic measuring of the displacement of the membranes which corresponds to the generated vacuum. |
| Maximum vacuum mmHg/kPa | Approx. -290 mmHg / -40 kPa | Approx. -290 mmHg / -40 kPa |
| Vacuum range - double mmHg/kPa | -50 to -250mmHg ± 20 mmHg / | |
| -7 to -33 kPa ± 3 kPa | ||
| (with Standard Program and 24 mm / size M PersonalFit breastshield) |
-70 to -250mmHg ± 20 mmHg /
-7 to -33 kPa ± 3 kPa
(with Preemie+ Program and 24 mm / size M PersonalFit breastshield) | -50 to -250mmHg ± 20 mmHg /
-7 to -33 kPa ± 3 kPa
(with Standard Program and 24 mm / size M PersonalFit breastshield) |
| Vacuum range - single mmHg/kPa | -50 to -250mmHg ± 20 mmHg /
-7 to -33 kPa ± 3 kPa
(with Standard Program and 24 mm / size M PersonalFit breastshield)
-70 to -250mmHg ± 20 mmHg /
-7 to -33 kPa ± 3 kPa
(with Preemie+ Program and 24 mm / size M PersonalFit breastshield) | -50 to -250mmHg ± 20 mmHg /
-7 to -33 kPa ± 3 kPa
(with Standard Program and 24 mm / size M PersonalFit breastshield) |
| Adjustable Suction Levels | 16 levels | 16 levels |
| Cycling Control Mechanism | Electronic measuring of the Motor speed and position. | Electronic measuring of the Motor speed and position. |
| | Symphony (Current Version) | Symphony (Predicate Version) |
| | | K020518 |
| Cycle Speed | 54 – 120 Cycles/Minute
(with Standard Program)
35 – 120 Cycles/Minute
(with Preemie+ Program) | 54 – 120 Cycles/Minute
(with Standard Program) |
| Overflow
protection | A Protection Membrane on the pump
side acts as a media separation and
prevents milk from going into the
pump in case of a milk overflow into
the vacuum tubes. | A Protection Membrane on the pump
side acts as a media separation and
prevents milk from going into the
pump in case of a milk overflow into
the vacuum tubes. |
| Software Cards | Standard 2.0 or Preemie+ program
cards, each featuring stimulation and
expression phases to assist for the
initiation, coming to volume, and/or
maintenance of lactation.
Vacuum range and cycle speed are
dependent on the breast pump suction
patterns.
The Standard 2.0 program consists of
two different curves.
The Preemie+ initiation program
consists of three different curves:
Standard 2.0 program card: Standard
program only.
Preemie+ program card: Standard 2.0
and Preemie+ programs. | Standard program card featuring
stimulation and expression phases to
assist for the coming to volume,
and/or maintenance of lactation.
Vacuum range and cycle speed are
dependent on the breast pump suction
patterns.
The Standard program consists of two
different curves.
The Standard program card includes
the Standard program only |
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8
9
SUMMARY OF NON-CLINICAL TESTS:
The Symphony breast pump complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and powered suction pumps. The following data were provided in support of the substantial equivalence determination:
- . Risk Analysis developed in accordance with ISO 14971: 2007.
- . Sterilization information in accordance with FDA's guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile".
10
- . Cleaning Validation. Validation of cleaning methods, both manual cleaning with dish soap and cleaning in the dishwasher, and validation of the sanitation process with boiling water and the quick clean™ micro-steam™ bags were conducted. A selection of reusable breast pump kit components that contact breast milk representative of all Medela breast pump components, including those specified for use with Symphony, were challenged with a human breast milk solution containing organisms, cleaned, or sanitized according to the Instructions for Use and evaluated for the presence of surviving organisms. The validation protocol was based upon AAMI TIR30-2003, A Compendium of Processes, Materials, Test Methods, and Acceptance Criteria for Cleaning Reusable Medical Devices, 8 October 2003.
- . For sterile items, accelerated aging tests to support the labeled shelf life were conducted according to ASTM F1980 (07) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Testing was also conducted to verify drive unit life time in support of the breast pump service life specification.
- . Biocompatibility Evaluation was completed according to the FDA guidance "Use of International Standard ISO- 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and concluded that no new testing was required as all patient contacting materials are identical to those used in the predicate Symphony Breast Pump.
- . Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since prior to mitigations of hazards, failure of the software could lead to minor injury, such as pain or engorgement.
- . Electrical safety and electromagnetic compatibility testing per IEC 60601-1:2005 (3rd Edition) with US deviations per AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 standard and IEC 60601-1-2: 2007 standards, respectively
- . Safety testing for use in the home per IEC 60601-1-11: 2010 standard
- . Performance testing demonstrating compliance with EN ISO 10079-1: 2009 Particular requirements for the safety of electrically powered suction equipment
- . Performance testing at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications, which are identical to those of the predicate version of the Symphony pump. Tests were conducted over 20 minutes with the Standard 2.0 program card or 15 minutes with the Preemie+ program card to simulate a typical pumping session using size medium (M) breast shields. Tests began in stimulation mode and continued with expression mode after the first two minutes. There are two approved suppliers of the motor for the Symphony® breast pump. Testing of six pumps was completed with the Standard 2.0 program card, using three pumps with each motor type. One of each pump type was used for testing with the Preemie+ program card. Vacuum performance during normal use was first evaluated and demonstrated that, independent of the pump
11
motor type, the specification for vacuum level and cycle rate is met. Additional test cases evaluated performance of the pump when running on battery, performance with varying input voltages and with the other size breast shields. Finally, testing of performance for single pumping was completed. Results demonstrated that independent of the pump motor type, the specification for battery operation time is met, that the specification for vacuum level and cycle rate is met in single pumping mode as well as with all power source and with varying input voltage. With different breast shield sizes, the specification for the maximum vacuum level is met.
SUMMARY OF CLINICAL TESTS:
Clinical testing was not required to demonstrate the substantial equivalence of the Symphony breast pump to its predicate device. However, published research studies are referenced to support marketing claims.
CONCLUSION:
The differences between the Symphony breast pump and its predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended.
From the results of nonclinical testing described, Medela AG concludes that the Symphony breast pump is substantially equivalent to the legally marketed predicate device.