(370 days)
Not Found
No
The summary describes a standard electric breast pump with different power options and modes. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
No
The primary function of the electric breast pump is to express and collect milk, which is not considered a therapeutic function. While it can alleviate engorgement, this is an ancillary benefit of milk expression rather than a direct therapeutic intervention for a disease or condition.
No
The device description and intended use state that the Electric Breast Pump is used to express and collect milk, alleviate engorgement, and maintain lactation ability. None of these functions are diagnostic in nature; they are therapeutic/supportive.
No
The device description explicitly states it is an "Electric Breast Pump" with two models, capable of single and double pumping, and powered by AC, rechargeable battery, or AA batteries. This indicates a physical hardware device, not software only. The performance studies also include electrical safety, biocompatibility, and physical performance testing, further confirming it is a hardware device.
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 a lactating woman's breast. This is a physical process involving the body directly, not the examination of samples taken from the body.
- Device Description: The description focuses on the mechanical function of the pump and its power sources. There is no mention of analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are typically used to diagnose, monitor, or screen for diseases or conditions by examining samples like blood, urine, tissue, etc. This device does not perform any such analysis.
The device 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 therapeutic or supportive purpose (expressing milk).
N/A
Intended Use / Indications for Use
The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for a single user in a home or hospital environment.
Product codes
HGX
Device Description
The Electric Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. This Electric Breast Pump is intended for a single user in a home or hospital environment.
The Electric Breast Pump has two models: XN/MS-2224A and XN/MS-2224B. Both models are capable of single and double pumping and have two modes: stimulation and expression mode. Both models can be operated using AC power, a built-in rechargeable li-ion polymer battery, or AA batteries.
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
Home or hospital environment, single user.
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 performance data were provided in support of a substantial equivalence determination:
- a. Electrical Safety and Electromagnetic Compatibility:
- IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for basic safety, and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility
- IEC 62133:2012 - Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- b. Biocompatibility:
- Biocompatibility testing in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments:
- Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- Sensitization per ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- Irritation per ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- The user-contacting materials were shown to be non-cytotoxic, non-sensitizing, and non-irritating.
- Biocompatibility testing in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments:
- c. Software Verification:
- Software verification and validation in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
- d. Performance testing:
- Vacuum pressure and cycle rate testing was conducted at all settings for each device model.
- Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump.
- Use life testing of vacuum level and battery performance
- Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.5160 Powered breast pump.
(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 4, 2021
Guangdong Horigen Mother & Baby Products Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K201152
Trade/Device Name: Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: March 29, 2021 Received: April 2, 2021
Dear Olivia Meng:
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/cdrl/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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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/cdrl-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,
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) K201152
Device Name Electric Breast Pump
Indications for Use (Describe)
The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for a single user in a home or hospital environment.
| 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
K201152
1. SUBMITTER
| Name: | Guangdong Horigen Mother & Baby Products Co., Ltd. |
|---|---|
| Address: | No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang |
| District, 515100 Shantou, Guangdong, China | |
| Phone: | +86-754-83613668 |
| Fax: | +86-754-83843338 |
| Primary Contact Person: | Olivia Meng |
| Regulatory Affairs Manager | |
| Guangzhou Osmunda Medical Device Technical Service Co., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86) -20-8633 0253 | |
| Secondary Contact Person: | Changxin Chen |
| General Manager Assistant | |
| Guangdong Horigen Mother & Baby Products Co., Ltd. | |
| Tel: (+86)-754-83613668-866 | |
| Fax: (+86)-754-83843338 | |
| Date prepared: | May 3, 2021 |
| 2. DEVICE | |
| Device Name/Trade Name: | Electric Breast Pump |
| Models: | XN/MS-2224A and XN/MS2224B |
| Common Name: | Powered breast pump |
| Regulation Number: | 21 CFR 884.5160 |
| Regulation Name: | Powered Breast Pump |
| Product Code: | HGX (Pump, Breast, Powered) |
| Regulatory Class: | Class II |
| 3. PREDICATE DEVICE | |
| 510(k) Number: | K181784 |
| Manufacturer: | Uzinmedicare Co. |
| Device Name: | Spectra S3 Plus Breast Pump |
| The predicate device has not been subject to a design-related | |
| recall. |
4
DEVICE DESCRIPTION 4.
The Electric Breast Pump is intended to express and collect milk from the mother's breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. This Electric Breast Pump is intended for a single user in a home or hospital environment.
The Electric Breast Pump has two models: XN/MS-2224A and XN/MS-2224B. Both models are capable of single and double pumping and have two modes: stimulation and expression mode. Both models can be operated using AC power, a built-in rechargeable li-ion polymer battery, or AA batteries.
5. INDICATIONS FOR USE
The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for a single user in a home or hospital environment.
COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS 6.
The following table compares the subject device to the predicate device with respect to the indications for use and technological characteristics:
| Specification | Subject Device | Predicate Device |
|---|---|---|
| Electric Breast Pump | ||
| K201152 | Spectra S3 Plus Breast Pump | |
| K181784 | ||
| Indications for Use | The Electric Breast Pump is intended to be used by lactating women to express and collect milk from their breast, to alleviate engorgement of the breast, maintain the ability of lactation, and provide mother's milk for future feedings when separation of mother and baby occurs. It is intended for a single user in a home or hospital environment. | The Spectra 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user. |
| Patient Population | Lactating women | Lactating women |
| Use Environment | Hospital and home | Hospital and home |
| Pump Style | Diaphragm pump | Diaphragm pump |
| Pumping Option | Single or Double | Single or Double |
| Adjustable Levels | ||
| (Stimulation Mode) | Suction Strength | |
| XN/MS-2224A: 7 levels | ||
| XN/MS-2224B: 7 levels | 12 levels | |
| Cycle Speed | ||
| XN/MS-2224A: 3 levels | ||
| XN/MS-2224B: 3 levels | N/A | |
| Adjustable Levels | ||
| (Expression Mode) | Suction Strength | |
| XN/MS-2224A: 10 levels | ||
| XN/MS-2224B: 12 levels | 12 levels | |
| Cycle Speed | ||
| XN/MS-2224A: 6 levels | ||
| XN/MS-2224B: 6 levels | N/A |
5
| Cycle speed
(cycles/min)
Stimulation Mode | XN/MS-2224A: 70-105
XN/MS-2224B: 70-105 | 38-70 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| Suction Strength
(mmHg)
Stimulation Mode | XN/MS-2224A:
Single 37.5-187.5 mmHg
Double 15-105 mmHg
XN/MS-2224B:
Single 37.5-187.5 mmHg
Double 15-105 mmHg | 50 (±50) mmHg to 270 (-50 mmHg) |
| Cycle speed
(cycles/min)
Expression Mode | XN/MS-2224A: 34-54
XN/MS-2224B: 34-54 | 38-70 |
| Suction Strength
(mmHg)
Expression Mode | XN/MS-2224A:
Single 75-247.5 mmHg
Double 15-195 mmHg
XN/MS-2224B:
Single 75-247.5 mmHg
Double 15-225 mmHg | 50 (±50) mmHg to 270 (-50 mmHg) |
| Maximum Suction
Strength (mmHg) | 247.5 | 270 |
| Backflow protection | Yes | Yes |
| Visual indicator | LED Display | LCD Display |
| Power source | a. AC/DC adapter
b. Rechargeable li-ion battery | a. AC/DC Adapter
b. Rechargeable li-ion battery |
The subject and predicate device have similar indications for use statements. They both are intended to be used to express and collect milk for the breast of lactating women.
The subject and predicate device have different technological features, including the user interface, expression levels, suction strength, cycle speed, and power source. These technological differences do not raise different questions of safety or effectiveness.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
The following performance data were provided in support of a substantial equivalence determination:
- a. Electrical Safety and Electromagnetic Compatibility:
- . IEC 60601-1:2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical electrical equipment – Part 1: General requirements for basic safety, and essential performance with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- . IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General
6
requirements for basic safety, and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- IEC 60601-1-2:2014, Medical electrical equipment Part 1-2: General requirements ● for basic safety and essential performance – Collateral Standard: Electromagnetic Compatibility
- IEC 62133:2012 - Secondary cells and batteries containing alkaline or other nonacid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
b. Biocompatibility:
Biocompatibility testing in accordance with the FDA guidance "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020. Testing included the following assessments:
- Cytotoxicity per ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- Sensitization per ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- . Irritation per ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
The user-contacting materials were shown to be non-cytotoxic, non-sensitizing, and non-irritating.
- c. Software Verification:
- Software verification and validation in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May 11, 2005.
- d. Performance testing:
- Vacuum pressure and cycle rate testing was conducted at all settings for each device model.
- Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump.
- Use life testing of vacuum level and battery performance
- Battery status indicator testing was conducted to demonstrate that the battery ● status indicator remains functional during its stated battery life.
8. CONCLUSION
The nonclinical performance testing described above demonstrate that the Electric Breast Pump is as safe and effective as the predicate device and supports a determination of substantial equivalence.