(128 days)
The Sonata breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Sonata breast pump is intended for a single user.
The Sonata™ breast pump and kit are used to express and collect mills from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. The system is not designed for mobile use. Pumping with the Sonata™ breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). Two suction rhythms are pre-programmed with variable vacuum levels and cycle rates (pump speed). The Sonata™ breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 120 cycles per minute.
The provided document is a 510(k) summary for the Medela Sonata™ breast pump. It primarily focuses on demonstrating substantial equivalence to a predicate device (Medela Symphony Breast Pump) rather than detailing a study that meets specific acceptance criteria for a device performance. Therefore, most of the requested information regarding "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of clinical performance or algorithm performance is not present in this regulatory document.
However, I can extract information related to non-clinical tests conducted to support substantial equivalence.
Here's the breakdown of what can be inferred and what is not available from the document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria for a clinical performance study or an algorithm; instead, it lists non-clinical tests performed to demonstrate safety and performance compared to a predicate device. The "acceptance criteria" here are implicitly tied to meeting the standards of these non-clinical tests and demonstrating comparable performance to the predicate.
Here's a summary of performance-related information:
| Aspect | Acceptance Criteria (Implied / Comparator) | Reported Device Performance (Sonata™) |
|---|---|---|
| Pumping Mechanism | Equivalent function to predicate | Linear piston, microprocessor-controlled DC motor drives linear element to create volumetric expansion and vacuum. |
| Vacuum Range (Double) | Similar to predicate | -50 to -240mmHg ± 10 mmHg / -7 to -32 kPa ± 3 kPa (with 21, 24, 27, 30, and 36mm breast shield sizes) |
| Vacuum Range (Single) | Similar to predicate | -50 to -240mmHg ± 10 mmHg / -7 to -32 kPa ± 3 kPa (with 21, 24, 27, 30, and 36mm breast shield sizes) |
| Adjustable Suction Levels | Numeric comparison to predicate | 10 levels |
| Cycle Speed | Similar to predicate | 54 – 120 Cycles/Minute |
| Overflow Protection | Effective milk separation | A Protection Membrane on the kit side acts as a media separation and prevents milk from going into the pump. |
| Operation Time (Battery) | Similar to predicate | Approx. 60 minutes |
| Charging Time | Similar to predicate | Approx. 4 hours |
| Electrical Safety | Compliance with IEC 60601-1:2005 (3rd Ed.) & AAMI/ANSI ES60601-1:2005/(R)2012 & A1:2012 | Complies with specified standards |
| EMC | Compliance with IEC 60601-1-2: 2014 | Complies with specified standards |
| Home Healthcare Safety | Compliance with IEC 60601-1-11: 2010 | Complies with specified standards |
| Risk Management | Compliance with ISO 14971:2007 | Risk Analysis developed in accordance with ISO 14971:2007 |
| Biocompatibility | No new testing required per ISO 10993 | Patient contacting materials are identical to those used in the predicate Symphony Breast Pump, thus no new testing. |
| Software V&V | Compliance with FDA Guidance for Software in Medical Devices | Conducted, documentation provided; software considered "moderate" level of concern. |
| Performance Testing | Ensure comparable vacuum performance, stability, battery, overflow, design life, durability, acoustic | Performed to determine vacuum performance (min/max), vacuum stability, battery performance, overflow performance, design life, durability, and acoustic testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document, as it outlines non-clinical testing rather than a clinical study with a "test set" of patient data. The tests refer to device-specific performance evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the non-clinical tests described. No "ground truth" established by human experts is mentioned for a test set in the context of clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable to the non-clinical tests described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a breast pump, not an AI-powered diagnostic tool, and therefore, no MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a breast pump, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable to the non-clinical tests described. The "ground truth" for the non-clinical tests is based on objective measurements against engineering specifications and voluntary standards.
8. The sample size for the training set
This information is not applicable. This is a physical device, not an AI model requiring a training set of data.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2016
Medela, Inc. % Adrienne Lenz Member Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman, Wisconsin 53118
Re: K161725
Trade/Device Name: Sonata™ breast pump and accessories Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: Class II Product Code: HGX Dated: September 23, 2016 Received: September 27, 2016
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 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
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device-related adverse events) (21 CFR 803); 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.
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,
| For Division | Douglas Silverstein -S |
|---|---|
| 2016.10.28 08:35:06 -04'00' | |
| 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
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Indications for Use
510(k) Number (if known) K161725
Device Name Sonata™ breast pump and accessories
Indications for Use (Describe)
The Sonata breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Sonata breast pump is intended for a single user.
| 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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510(k) Summary
K161725
In accordance with 21 CFR 807.92 the following summary of information is provided:
DATE: October 26, 2016
SUBMITTER:
Medela Inc. 1101 Corporate Drive McHenry, IL 60050 Phone: (815) 578-2270 Fax: (815) 759-2548
PRIMARY CONTACT PERSON:
Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman, Wisconsin 53118 Phone: (262) 290-0023
SECONDARY CONTACT PERSON:
Robert Sokolowski Director, Quality Assurance Medela Inc.
DEVICE:
TRADE NAME: Sonata™ breast pump and accessories
Models: 58200 Sonata™ Breastpump Deluxe, 68053 Double Pumping Kit, retail, 68054 Connector spare parts kit, 68055 Silicone Membrane, retail, includes 2 silicone membranes, 68050 Power Adaptor, retail, 68052 Carry Bag, retail, 58105 Sonata™ Warranty Breast pump
COMMON/USUAL NAME: Powered Breast Pump
REGULATORY CLASS: Class II
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CLASSIFICATION NAME: 21 CFR 884.5160 (Powered breast pump)
PRODUCT CODE: HGX (Pump, Breast, Powered)
PREDICATE DEVICE:
K151632; Medela Symphony Breast Pump. The predicate device has not been subject to a design-related recall.
DEVICE DESCRIPTION:
The Sonata™ breast pump and kit are used to express and collect mills from the breast of a lactating woman. The system is intended for daily use in a home (or similar environment such as an office) to supplement breastfeeding by a single user. The system is not designed for mobile use. Pumping with the Sonata™ breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).
Two suction rhythms are pre-programmed with variable vacuum levels and cycle rates (pump speed). The Sonata™ breast pump is capable of providing vacuum levels from -50 to -240 mmHg with cycle rates up to 120 cycles per minute.
The Sonata™ breast pump provides the following user features:
- Gear-driven vacuum pump design (linear piston), for quiet operation.
- LCD display, for user assistance/device status.
- Capacitive touch controls for user adjustment of vacuum level/cycles, phase selection "Letdown", pattern selection, and audio chimes.
- 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.
- "Let-down" control to change between stimulation phase and expression phase.
- Option of either single or double breast pumping.
- 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.
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For a full list of device specifications, please see the Table 1. Comparison of Sonata to Predicate Device.
INDICATIONS FOR USE:
The Sonata™ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Sonata breast pump is intended for a single user.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE
The indications for use of Medela's Sonata™ breast pump are the same as the predicate devices with the additional statement that it is intended for a single user. The subject and predicate device have the same intended use – to express and collect milk from the breast.
Sonata™ and the predicate device generate vacuum in a similar manner. A microprocessorcontrolled DC motor provides motive force to a drive train which in turn moves a linear element to create volumetric expansion and vacuum.
The table below identifies key similarities and differences of the proposed Sonata breast pump to the legally marketed predicate device, the Symphony breast pump (K151632).
| Sonata ™ (Subject Device),K161725 | Symphony ™ (Predicate Device),K151632 | |
|---|---|---|
| Indications forUse | The Sonata™ breast pump is apowered breast pump to be usedby lactating women to expressand collect milk from their breast.The Sonata™ breast pump isintended for a single user. | The Symphony™ breast pump is apowered breast pump to be used bylactating women to express andcollect milk from their breast. |
| Environment ofUse | Home | Hospital, Home |
| Sonata™ (Subject Device),K161725 | Symphony™ (Predicate Device),K151632 | |
| User Interface | Hardware interfaces | Hardware interfaces |
| User Control | State-dependent controls:Power Button (physical Switch)Capacitive touch switches for:• One Touch Let-Down• Silence Control• Start/Stop /Pause• Timer• Rhythm (Pattern) Selection• "Plus" increment value buttonused to adjust vacuum andtimer settings• "Minus" decrement valuebutton used to adjust vacuumand timer settings | State-dependent controls:On-Off membrane switchLet-Down Button (membraneswitch), also used to select thePreemie+ initiation programValue-adjustment rotary control:Vacuum/Cycle-adjustment control |
| Visual Indicator | Liquid-crystal display (LCD)Light Emitting Diodes (LED)surrounding start/stop button:white at power up, green whenpumping, flashing green whenpaused. | Liquid-crystal display |
| Audible Indicator | Internal Speaker (not alarm).Notification Chimes:• Button press• Button bookend (end ofrange reached)• Leak chime• Leak resolved chime• Timer chime• Letdown chime | None |
| Single/DoublePumping | Single and double pumping | Single and double pumping |
| Sonata™ (Subject Device),K161725 | Symphony™ (Predicate Device),K151632 | |
| Accessories | Breast shield Breast shield connector Valve Membrane Tubing Pump and Save Bags Power Supply Cooler Carry bag Closures/lids (for bottles) Collection Containers | 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 |
| Cleaning | Breastpump/case - wipe with clean, damp cloth Tubing - wash only if milk or condensation in tubing Breast pump kit and bottles - wash and sanitize | 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 |
| Specifications | ||
| Power Source | 100-240 Vac50/60Hz | 100-240 Vac50/60Hz0.3A |
| Batteries | 2 x 3.6V/2.2AhRechargeable LION Batteries | 2 x 6V/1.2AhRechargeable Pb Batteries |
| Batterycharge/discharge | Operation time: approx. 60 minutesCharging time: approx. 4 hours | Operation time: approx. 1 hourCharging time: approx. 4 hours (80%)approx. 8 hours (100%) |
| Housing Material | Polycarbonate | Polyamide |
| Sonata™ (Subject Device),K161725 | Symphony™ (Predicate Device),K151632 | |
| Vacuumaggregate type | Linear piston | Diaphragm pumpTwo diaphragms - for left and rightbreastLinear movement by driving bars |
| VacuumRegulation type | Electronic measuring of thedisplacement and pressure of thepiston which corresponds to thegenerated vacuum. | Electronic measuring of thedisplacement of the membraneswhich corresponds to the generatedvacuum. |
| Vacuum range -doublemmHg/kPa | -50 to -240mmHg ± 10 mmHg /-7 to -32 kPa ± 3 kPa(with 21, 24, 27, 30, and 36mmbreast shield sizes) | -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) |
| Vacuum range —single mmHg/kPa | -50 to -240mmHg ± 10 mmHg /-7 to -32 kPa ± 3 kPa(with 21, 24, 27, 30, and 36mmbreastshield sizes) | -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) |
| AdjustableSuction Levels | 10 levels | 16 levels |
| Cycling ControlMechanism | Electronic measuring of the Motorspeed, position and vacuum. | Electronic measuring of the Motorspeed and position. |
| Cycle Speed | 54 – 120 Cycles/Minute | 54 – 120 Cycles/Minute(with Standard Program)35 – 120 Cycles/Minute(with Preemie+ Program) |
| Sonata™ (Subject Device),K161725 | Symphony™ (Predicate Device),K151632 | |
| Overflowprotection | A Protection Membrane on the kitside acts as a media separationand prevents milk from going intothe pump. | A Protection Membrane on thepump side acts as a media separationand prevents milk from going intothe pump in case of a milk overflowinto the vacuum tubes. |
| Software | Embedded | Embedded, 2 software cards(Standard 2.0, Preemie+) |
| PumpingRhythms | Rhythm 1 and Rhythm 2, eachfeaturing stimulation andexpression. | Standard 2.0 or Preemie+ programcards, each featuring stimulation andexpression phases. |
TABLE 1. COMPARISON OF SONATA TO PREDICATE DEVICE
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The technological characteristics of the subject device are different – the subject device utilizes a different vacuum pumping mechanism, has a different user interface, different material components, batteries, dimensions, weight, operating and storage temperature/humidity, suction levels, cycle speeds, and overflow protection mechanisms. However, different types of safety or effectiveness questions are not raised by these differences in technological characteristics.
SUMMARY OF NON-CLINICAL TESTS:
The Sonata breast pump complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and usability. The following data were provided in support of the substantial equivalence determination:
- Risk Analysis developed in accordance with ISO 14971:2007 Medical devices – Application of risk management to medical devices.
- . 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.
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- . 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: 2014 standards, respectively
- . Safety testing for use in the home per IEC 60601-1-11: 2010 standard
- . Performance Testing to determine the vacuum performance, including minimum and maximum vacuum levels for the pump as compared to the predicate device, vacuum stability, battery performance, overflow performance, design life, durability, and acoustic testing.
CONCLUSION:
The differences between the Sonata 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 Inc. concludes that the Sonata breast pump is as safe and as effective as the predicate device and supports a determination of substantial equivalence.
§ 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).