(275 days)
Not Found
No
The description mentions a microprocessor controlling vacuum pressure and cycle speed, which is standard for electronic devices and does not indicate AI/ML. There is no mention of learning, adaptation, or complex data processing beyond basic control functions.
No.
The device's intended use is to express and collect milk from the breast, which is not considered a therapeutic act but rather a support for lactation.
No
The device description clearly states its purpose is to "express and collect milk from their breast," which is a functional purpose, not a diagnostic one. There is no mention of it analyzing health conditions or providing diagnostic information.
No
The device description clearly outlines hardware components such as a vacuum pump, microprocessor, panel keypad, LED/LCD display, power source (USB/battery), breast shield, tubing, and other physical accessories. The performance studies also include electrical safety, biocompatibility, and performance testing related to the physical operation of the pump.
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 mechanical device that uses vacuum pressure to extract milk. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly a medical device, but its function is related to physical extraction, not in vitro analysis.
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. It is intended for a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Electric breast pump is a single-patient reusable device, intended to be used by lactating women to express and collect milk from their breasts. The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed.
The Electric Breast pump has two models: RH-228 and RH-338. Model RH-228 is capable of single pumping and has two modes - stimulate mode and expression mode. The RH-228 user interface consists of a panel keypad and LED display in which the user switches between modes and controls the vacuum pressure. Model RH-338 is capable of single pumping and has three modes - stimulate mode, massage mode and expression mode. The RH-338 user interface consists of a panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure.
The RH-228 is externally powered by 5Vdc USB. The RH-338 is internally powered by 3.7Vdc lithium battery or externally powered by 5Vdc USB. The external adapter also charges the battery.
Both models of the Electric breast pump are provided with a breast shield, cylinder cap, cylinder, valve, vacuum tubing, feeding bottle, and a nipple kit. Model RH-338 also includes a massage cushion and a dust cap. The user-contacting materials are limited to polypropylene (breast shield) and silicone (massage cushion).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Not Found
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)
Non-clinical tests were conducted to verify that the proposed device met all design specifications and that the subject devices are substantially equivalent to the predicate device.
-
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 biocompatible. -
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 and demonstrated that the devices met their specifications.
- . Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump.
- Battery performance testing was conducted to demonstrate that the battery . remains functional during its stated battery use-life.
- 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): 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.
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
Předetermined 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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in a clear, sans-serif font, with "FDA" in a blue box.
April 9, 2021
Cixi Ruihong Electric Appliance Co., Ltd. Kelong Zhang General Manager No. 18, Xiamaojia Road, Shuangqingpu Village, Xinpu Town, Cixi Ningbo. Zhejiang 315322 China
Re: K201903
Trade/Device Name: Electric breast pump (Models: RH-228 and RH-338) Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 9, 2021 Received: March 8, 2021
Dear Kelong Zhang:
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.
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.
1
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/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,
Michael T. Bailey -S
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201903
Device Name
Electric breast pump (Models: RH-228 and RH-338)
Indications for Use (Describe)
The Electric breast pump is intended to be used by lactating women to express and collect milk from their breast. It 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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3
510(k) Summary
K201903
1. Submitter Information:
| Name: | Cixi Ruihong Electric Appliance Co., Ltd. |
|---|---|
| Address: | No.18, Xiamaojia Road, Shuangqingpu Village, |
| Xinpu Town, Cixi, Ningbo, 315322, Zhejiang, China |
| Contact Person: | Mr. Kelong Zhang |
|---|---|
| Position: | General Manager |
| Phone: | +86-574-63581761 |
| Fax: | +86-574-63581761 |
| Email: | 1020666000@qq.com |
Date 510(k) Summary Prepared: April 7, 2021
2. Device Information
Trade/Proprietary Name: Electric breast pump (Models: RH-228 and RH-338)
| Regulation Name: | Powered breast pump |
|---|---|
| Regulation Number: | 21 CFR 884.5160 |
| Common Name: | Powered breast pump |
| Product Code: | HGX (Pump, Breast, Powered) |
| Regulatory Class: | Class II |
| Review Panel: | Obstetrics/Gynecology |
3. Predicative Device
| 510(k) Number: | K163136 |
|---|---|
| Manufacturer: | Ningbo Youhe Electrical Appliance Technology Co., Ltd. |
| Device Name: | Youha electric breast pump (Model: YH-8006IV) |
The predicate device has not been subject to a design-related recall.
4. Device Description:
The Electric breast pump is a single-patient reusable device, intended to be used by lactating women to express and collect milk from their breasts. The device uses a diaphragm-type vacuum pump driven by a microprocessor. The microprocessor provides control over vacuum pressure and cycle speed.
4
The Electric breast pump has two models: RH-228 and RH-338. Model RH-228 is capable of single pumping and has two modes - stimulate mode and expression mode. The RH-228 user interface consists of a panel keypad and LED display in which the user switches between modes and controls the vacuum pressure. Model RH-338 is capable of single pumping and has three modes - stimulate mode, massage mode and expression mode. The RH-338 user interface consists of a panel keypad and LCD display in which the user switches between modes and controls the vacuum pressure.
The RH-228 is externally powered by 5Vdc USB. The RH-338 is internally powered by 3.7Vdc lithium battery or externally powered by 5Vdc USB. The external adapter also charges the battery.
Both models of the Electric breast pump are provided with a breast shield, cylinder cap, cylinder, valve, vacuum tubing, feeding bottle, and a nipple kit. Model RH-338 also includes a massage cushion and a dust cap. The user-contacting materials are limited to polypropylene (breast shield) and silicone (massage cushion).
5. Indications for Use
The Electric breast pump is intended to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
6. Comparison of Intended Use and Technological Characteristics
The following table compares the subject device to the predicate device with respect to the indications for use and technological characteristics:
| Characteristics | Subject Device
Electric breast pump
K201903 | Predicate Device
Youha Electric Breast Pump
ModelYH-8006IV
K163136 | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Indications for Use | The Electric breast pump is
intended to be used by
lactating women to express
and collect milk from their
breasts. It is intended for a
single user. | The Youha electric breast pump
is intended to be used by
lactating women to express and
collect milk from their breasts. It
is intended for a single user. | |
| Single-user | Yes | Yes | |
| Provided | Yes | Yes | |
| Non-sterile | | | |
| Re-usable | | Yes | Yes |
| Direct user contact | | Yes | Yes |
| Patient population | | Lactating women | Lactating women |
| Anatomical Sites | | Breast | Breast |
| Suction strength
(mmHg) | RH-228 | Expression mode:
120-275
Stimulate mode:
60-150
Massage mode:
135-255 | High expression mode:125-280
Massage mode: 50-190 |
| | RH-338 | Stimulate mode:
45-165
Expression mode:
110-300 | |
| Suction Levels | RH-228 | Expression mode: 4
levels
Stimulate mode: 5
levels | 10 levels |
| | RH-338: 9 levels | | |
| Cycle Speed
(cycles/min) | RH-228 | Expression mode:
28-52
Stimulate mode:
58-90
Massage mode:
56-72 | High expression mode:32-57
Massage mode: 71-100 |
| | RH-338 | Stimulate mode:
115-155
Expression mode:
25-52 | |
| Backflow
protection | | Yes | Yes |
| Single or Double
pumping | | Single pumping | Single Pumping |
| Visual Indicator | | RH-228: LED
RH-338: LCD | LCD |
| Pump Type | | Diaphragm | Diaphragm |
5
6
The subject and predicate device have identical indications for use statements. Therefore, they have the same intended use, i.e., for collection of breast milk from the breasts of a single user.
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
Non-clinical tests were conducted to verify that the proposed device met all design specifications and that the subject devices are substantially equivalent to the predicate device.
- 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
7
-
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 biocompatible. -
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 and demonstrated that the devices met their specifications.
- . Backflow testing was conducted to demonstrate that liquid does not backflow into the tubing/pump.
- Battery performance testing was conducted to demonstrate that the battery . remains functional during its stated battery use-life.
- Battery status indicator testing was conducted to demonstrate that the battery . status indicator remains functional during its stated battery life.
8. Conclusion:
The comparison and analysis above demonstrate that the Electric breast pump is as safe and effective as the predicate device and supports a determination of substantial equivalence to the predicate device.