(273 days)
No
The description focuses on basic electronic controls (buttons, vacuum levels, modes) and standard electrical/mechanical performance testing. There is no mention of adaptive algorithms, learning from user data, or any features that would typically indicate AI/ML. The software validation is described as "Moderate" level of concern, which is common for devices with basic control logic, not complex AI/ML.
No.
The device is a breast pump used by lactating women to express and collect milk, which is not considered a therapeutic function.
No
The device is a breast pump, used to express and collect milk, not to diagnose a medical condition.
No
The device description clearly outlines physical components such as a powered breast pump, buttons, a power adapter, and an internal rechargeable battery. The performance studies also include testing related to electrical safety, electromagnetic compatibility, and bench testing of vacuum and cycles, all of which are associated with hardware. While software validation is mentioned, it is for "Software Contained in Medical Devices," indicating the software is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breast." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a powered breast pump that applies vacuum to the breast. This aligns with the intended use and does not involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on electrical safety, electromagnetic compatibility, risk analysis, software validation, and bench testing of the pump's mechanical performance (vacuum, cycles, battery life). These are typical tests for a medical device that interacts with the body, not for an IVD.
In summary, the Synergy Gold Portable breast pump is a medical device used for a physical process (expressing milk), not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Synergy Gold (SG) Portable (Models MM011450 and MM011460) breast pump is intended for home use by a single user.
Product codes
HGX
Device Description
The Synergy Gold (SG) Portable is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to select one or both sides for pumping, to switch from massage mode to expression mode and to control the vacuum levels within those modes. Massage mode consists of 5 suction levels, while expression mode has 12 suction levels. The SG Portable breast pump is capable of providing vacuum levels from 50-270 mmHz with cycling rate or 100 cycles per minute in massage mode and 26 cycles per minute in expression mode. The SG Portable breast pump is powered by a 5V DC adaptor or an internal rechargeable lithium-ion polymer battery.
The SG Portable breast pump is sold in two configurations (with and without breast shield and bottle sets). Model MM011450 includes the SG Portable breast pump, double collection kit (MM12302-C; breast shield set - medium 24 mm), power adapter, and two collection bottles. Model MM011460 includes the SG Portable breast pump and power adaptor: this model is to be used with separately purchased compatible breast shields and bottle sets.
The SG Portable breast pump and associated breast pump kits are intended for a single user.
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 / home use
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
Bench testing was conducted to demonstrate that the device meets its performance specifications. The testing involved measurement of vacuum and cycles for both single and double pumping. AC and battery power, performance with all breast shield sizes, and verification of backflow protection.
Battery and pump use-life testing was conducted to demonstrate that the device maintains its specifications throughout its use-life.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
October 19, 2021
Uzinmedicare Co. % Adrienne Lenz Senior Medical Device Regulation Expert Hyman, Phelps, & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, District of Columbia 20005
Re: K210124
Trade/Device Name: Synergy Gold (SG) Portable (Models MM011450 and MM011460) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: September 20, 2021 Received: September 21, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210124
Device Name
Synergy Gold (SG) Portable (Models MM011450 and MM011460)
Indications for Use (Describe)
The Synergy Gold (SG) Portable (Models MM011460) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Synergy Gold (SG) Portable (Models MM011450 and MM011460) breast pump is intended for home use by 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
K210124
DATE: October 18, 2021
SUBMITTER:
UZINMEDICARE CO
56, Dongtansandan 5-gil, Hwaseong-si, Gyeonggi-do, 18487 Republic of Korea
PRIMARY CONTACT PERSON:
Nathan Ahn, Manager Overseas Department c/o UZINMEDICARE CO 56, Dongtansandan 5-gil, Hwaseong-si, Gyeonggi-do, 18487 Republic of Korea Telephone: 82-31-739-5271 Email: shahn@uzinmedical.co.kr
SECONDARY CONTACT PERSON:
Heidi Humphries, RN, BSN, IBCLC Spectra Baby USA 6851 SW 21ST Court, Suite 1 Davie, FL 33317 Telephone: 954-471-4429 E-mail: hprn@aol.com
DEVICE:
TRADE NAME: Synergy Gold (SG) Portable (Models MM011450 and MM011460) COMMON/USUAL NAME: Powered Breast Pump REGULATION NUMBER: 21 CFR 884.5160 REGULATION NAME: Powered Breast Pump
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PRODUCT CODE: HGX (Pump, Breast, Powered) REGULATORY CLASS: Class II REVIEW PANEL: Obstetrics/Gynecology
PREDICATE DEVICE(S):
K191208 Spectra Cashmere Breast Pump
The predicate device has not been subject to a design-related recall.
The Medela Pump In Style (K200508) was used as a reference device.
DEVICE DESCRIPTION:
The Synergy Gold (SG) Portable is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to select one or both sides for pumping, to switch from massage mode to expression mode and to control the vacuum levels within those modes. Massage mode consists of 5 suction levels, while expression mode has 12 suction levels. The SG Portable breast pump is capable of providing vacuum levels from 50-270 mmHz with cycling rate or 100 cycles per minute in massage mode and 26 cycles per minute in expression mode. The SG Portable breast pump is powered by a 5V DC adaptor or an internal rechargeable lithium-ion polymer battery.
The SG Portable breast pump is sold in two configurations (with and without breast shield and bottle sets). Model MM011450 includes the SG Portable breast pump, double collection kit (MM12302-C; breast shield set - medium 24 mm), power adapter, and two collection bottles. Model MM011460 includes the SG Portable breast pump and power adaptor: this model is to be used with separately purchased compatible breast shields and bottle sets.
The SG Portable breast pump and associated breast pump kits are intended for a single user.
INDICATIONS FOR USE:
The Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a powered breast pump to be used by lactating women to express and collect milk from their breast.
5
The Synergy Gold (SG) Portable (Models MM011450 and MM011460) breast pump is intended for home use by a single user.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:
The Synergy Gold (SG) Portable breast pump represents a modification to the legally marketed predicate device (Spectra Cashmere Breast Pump, K191208) to which substantial equivalence is claimed. All patient and breast milk contacting materials are identical between the subject and predicate devices.
The table below compares the intended use and technological characteristics of the subject and predicate device.
| | Predicate Device
Spectra Cashmere Breast Pump
(K191208) | Subject Device
Synergy Gold Portable
(K210124) | Comparison |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Patient
Population | Breastfeeding women | Breastfeeding women | Same |
| Indications for
Use | The Spectra Cashmere Breast Pump
is a powered breast pump to be used
by lactating women to express and
collect milk from
their breast. The Spectra Cashmere
Breast Pump is intended for multiple
users in a hospital setting. It is also
intended for home use by a single
user. | The Synergy Gold (SG) Portable (Models MM011450
and MM011460) is a powered breast pump to be used
by lactating women to express and collect milk from
their breast. The Synergy Gold (SG) Portable (Models
MM011450 and MM011460) breast pump is intended
for home use by a single user. | Same
intended use |
| Environment
of Use | Hospital, Home | Home | Different |
| User Control | Touch switches to control
vacuum setting left/right pump right/left pump activation cycle speed setting mode of operation/mute night light power (on/off) | Touch switches to control vacuum setting left/right pump right/left pump activation mode of operation/mute Button to control power (on/off) | Different |
| Visual
Indicator | LED display indicates vacuum setting (each motor) cycle speed setting mode of operation pump operating time mute | LED display indicates vacuum setting (each motor) mode of operation pump operating time mute battery status | Different |
| | Predicate Device
Spectra Cashmere Breast Pump
(K191208) | Subject Device
Synergy Gold Portable
(K210124) | Comparison |
| Night Light | LED light with two lighting levels | None | Different |
| Modes of
Operation | Massage, Expression | Massage, Expression | Same |
| Single/Double
Pumping | Single or Double | Single or Double | Same |
| Accessories | Breast shield set, power adapter,
bottle set | Breast shield set, power adapter, bottle set | Same |
| Pump Type | Diaphragm | Diaphragm | Same |
| Suction Levels | 15 Levels | 12 Levels for expression
5 Levels for massage | Different |
| Suction
Strength | 50 (±50) mmHg to 270 (-50 mmHg)
(maximum 270 mmHg) | 50 (±50) mmHg to 270 (-50 mmHg) (maximum 270 mmHg) | Same |
| Cycle Levels | 5 levels for massage and 5 levels for
expression | 1 level for massage and 1 level for expression | Different |
| Cycle Speed | 38-76 cycles/min (adjustable) | 100 cycles/min for massage
26 cycles/min for expression | Different |
| Power Supply
(Conventional
Outlet) | AC/DC wall converter
Input 100V – 240AC, 50/60Hz,
500mA
Output : 12V, 2A | AC/DC wall converter
Input 100 – 240V, 50/60Hz, 500mA
Output : 5V, 2A | Different |
| Power Supply
(Battery) | No battery | Li-ion polymer 7.4vdc 1700mAh | Different |
| Back Flow
Protection | Yes, provided by silicone membrane
backflow protector | Yes, provided by silicone membrane backflow
protector | Same |
| Software | Yes | Yes | Same |
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The indications for use of the subject and predicate devices are not identical. Both the subject and predicate devices have the same intended use to express and collect milk from the breasts of a lactating woman and are for use by a single user in a home-use setting. The predicate device differs in that it can also be used in a hospital setting by multiple users. This difference does not represent a new intended use, but rather, a more limited use for the subject device.
7
The subject and predicate device have similar technological characteristics, including design, maximum vacuum level, modes of operation, back flow protection method, software control, and accessories. The different technological characteristics of the subject device, including visual indicators, user controls, number of vacuum and cycle levels, power adapter, battery operation, and lack of a night light function do not raise different questions of safety and effectiveness.
SUMMARY OF NON-CLINICAL TESTS:
The SG Portable breast pump complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and usability. The following performance data are provided in support of the substantial equivalence determination:
- Electrical Safety testing in accordance with the following standards: ●
- o ANSI/AAMI ES60601-1:2005+A1:2012
- o IEC 60601-1-11:2015
- o IEC 62133:2012
- Risk analysis in accordance with ISO 14971:2007 (Second Edition) ●
- Electromagnetic compatibility testing in accordance with IEC 60601-1-2:2014 ●
- Biocompatibility evaluation was not conducted on the patient-contacting materials ● of the device as all patient-contacting materials are identical to those used in the predicate device. Therefore, the biocompatibility information from the predicate device was used in support of the patient-contacting materials of the subject device.
- . The software validation was provided in accordance with the FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005. The software for the subject 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.
- Bench testing was conducted to demonstrate that the device meets its performance . specifications. The testing involved measurement of vacuum and cycles for both single and double pumping. AC and battery power, performance with all breast shield sizes, and verification of backflow protection.
- Battery and pump use-life testing was conducted to demonstrate that the device . maintains its specifications throughout its use-life.
CONCLUSION:
The non-clinical testing demonstrates that the SG Portable breast pump is as safe and effective as the predicate device.