Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail

• K Number: K161725
• Device Name: Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail
• Manufacturer: MEDELA, INC
• Date Cleared: 2016-10-28 ( 128 days)
• Product Code: HGX
• Regulation Number: 884.5160

Intended 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.

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.

Predicate Devices

K151632

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard powered breast pump with pre-programmed rhythms and variable vacuum levels. There is no mention of AI, ML, or any adaptive or learning capabilities. The performance studies focus on standard engineering metrics like vacuum performance, battery life, and durability, not on algorithmic performance.

Therapeutic

No.
The device is a breast pump used to express and collect milk, not to treat a disease or condition.

Diagnostic

No
The device is a breast pump, used to express and collect milk, and does not provide any diagnostic information or assessment of health conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "powered breast pump" and describes its physical components and performance characteristics like vacuum levels and cycle rates, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The Sonata breast pump is a mechanical device used to physically express and collect breast milk. It does not analyze any biological samples or provide diagnostic information about a person's health.
• Intended Use: The intended use is clearly stated as "to be used by lactating women to express and collect milk from their breast." This is a functional purpose, not a diagnostic one.

The information provided about performance testing, vacuum levels, and cycle rates relates to the mechanical operation and effectiveness of the pump, not to any diagnostic capabilities.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

HGX

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.

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 to express and collect milk from their breast. The system is intended for daily use in a home (or similar environment such as an office).

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)

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.
• 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K151632

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone]

PRIMARY CONTACT PERSON:

Adrienne Lenz, RAC Member Pathway Regulatory Consulting, LLC W324S3649 County Road E Dousman, Wisconsin 53118 Phone: [phone]

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 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. | 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 | 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 button
used to adjust vacuum and
timer settings
• "Minus" decrement value
button used to adjust vacuum
and timer settings | State-dependent controls:
On-Off membrane switch

Let-Down Button (membrane
switch), also used to select the
Preemie+ initiation program

Value-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 when
pumping, flashing green when
paused. | Liquid-crystal display |
| Audible Indicator | Internal Speaker (not alarm).

Notification Chimes:
• Button press
• Button bookend (end of
range reached)
• Leak chime
• Leak resolved chime
• Timer chime
• Letdown chime | None |
| Single/Double
Pumping | 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 Vac
50/60Hz | 100-240 Vac
50/60Hz
0.3A |
| Batteries | 2 x 3.6V/2.2Ah
Rechargeable LION Batteries | 2 x 6V/1.2Ah
Rechargeable Pb Batteries |
| Battery
charge/discharge | Operation time: approx. 60 minutes
Charging time: approx. 4 hours | Operation time: approx. 1 hour
Charging time: approx. 4 hours (80%)
approx. 8 hours (100%) |
| Housing Material | Polycarbonate | Polyamide |
| | Sonata™ (Subject Device),
K161725 | Symphony™ (Predicate Device),
K151632 |
| Vacuum
aggregate type | Linear piston | Diaphragm pump
Two diaphragms - for left and right
breast
Linear movement by driving bars |
| Vacuum
Regulation type | Electronic measuring of the
displacement and pressure of the
piston which corresponds to the
generated vacuum. | Electronic measuring of the
displacement of the membranes
which corresponds to the generated
vacuum. |
| Vacuum range -
double
mmHg/kPa | -50 to -240mmHg ± 10 mmHg /
-7 to -32 kPa ± 3 kPa
(with 21, 24, 27, 30, and 36mm
breast 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 36mm
breastshield 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) |
| Adjustable
Suction Levels | 10 levels | 16 levels |
| Cycling Control
Mechanism | Electronic measuring of the Motor
speed, position and vacuum. | Electronic measuring of the Motor
speed 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 |
| Overflow
protection | A Protection Membrane on the kit
side acts as a media separation
and prevents milk from going into
the pump. | 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 | Embedded | Embedded, 2 software cards
(Standard 2.0, Preemie+) |
| Pumping
Rhythms | Rhythm 1 and Rhythm 2, each
featuring stimulation and
expression. | Standard 2.0 or Preemie+ program
cards, each featuring stimulation and
expression 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.