(157 days)
The Electric Breast Pump Model: YM-8166 is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
The Electric Breast Pump Model: YM-8166 is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
The provided text is a 510(k) summary for an Electric Breast Pump Model: YM-8166. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing related to safety and effectiveness, rather than a clinical study evaluating the accuracy or performance of an AI/ML algorithm with human-in-the-loop.
Therefore, the specific information requested in the prompt, such as acceptance criteria for AI performance, sample sizes for test sets (in the context of AI models), expert ground truth, multi-reader multi-case studies, and training set information for AI, is not applicable to this device and the provided document.
The document describes the device's technical specifications and how they compare to a predicate device, along with the results of various engineering and biological safety tests.
Here's the relevant information that can be extracted from the provided text, framed in the context of device performance, rather than AI performance:
Acceptance Criteria and Device Performance (Non-AI/ML Device)
This device, an Electric Breast Pump, is a mechanical and electrical medical device. Its "performance" is assessed based on its ability to effectively and safely express milk, primarily through its engineering specifications and biological material compatibility, not through an AI algorithm's diagnostic or predictive accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Device Performance Aspect | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (from "Summary of Non-Clinical Performance Testing") |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing (per ISO 10993-5, -10, -23) | "The patient-contacting components of the subject device were shown to be non-cytotoxic, non-irritating, and non-sensitizing." |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2 | "Electrical safety and EMC testing was performed per the following standards:" (followed by a list of standards met) |
| Software Verification & Validation | Consistent with "basic level of concern" per FDA guidance, all software requirement specifications met, all software hazards mitigated. | "System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels." |
| Suction Strength & Cycle Speed | Complied with design specifications throughout use life. | "Suction strength and cycle speed of subject devices were tested. All the test results complied with the design specifications of the subject device throughout the use life." |
| Backflow Prevention | No liquid backflow into tubing/motor. | "Backflow testing was conducted... The test results showed that there was no backflow during the test." |
| Battery Performance | Remains functional during stated use-life. | "Battery performance testing was conducted to demonstrate that the battery remains functional during its stated use-life." |
| Battery Status Indicator | Remains functional during stated battery life. | "Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life." |
| Intended Use | Express milk from lactating women for collection (consistent with predicate). | "The Electric Breast Pump Model: YM-8166 is intended to express milk from lactating women in order to collect milk from their breasts." (Matches predicate's intended use). |
| Operational Characteristics | Similar to predicate, with differences not raising new safety/effectiveness questions (e.g., suction range, cycle speed). | "The Electric Breast Pump Model: YM-8166 has the same intended use, mode of action and similar operational characteristics as the predicate device... The different technological characteristics... do not raise different questions of safety and effectiveness." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of an AI algorithm. For non-clinical performance testing (e.g., biocompatibility samples, electrical safety tests, functional tests), the sample sizes are implicitly defined by the testing standards and protocols used. These are typically engineering samples of the device, not a "data set" of patient cases.
- Data Provenance: The testing was conducted by the manufacturer, Guangdong Youmeng Electrical Technology Co., Ltd., based in China. The nature of these tests (e.g., bench testing, material testing) means there's no patient data involved, hence no "retrospective or prospective" designation in the AI sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. This device does not use an AI/ML algorithm that requires expert annotation for ground truth. The "ground truth" for this device's performance is objective measurements (e.g., electrical readings, vacuum pressure, material properties) and laboratory test results as per established engineering and biocompatibility standards.
4. Adjudication Method for the Test Set
- Not applicable. No expert adjudication is described or required for the type of non-clinical, objective performance testing conducted for this device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is not an AI-assisted diagnostic device, so an MRMC study comparing human readers with and without AI assistance is not relevant or performed.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not applicable. There is no standalone AI algorithm for medical interpretation being evaluated. The device has embedded software for controlling the pump's functions (e.g., vacuum pressure, cycle speed), and its verification and validation are noted, but this is functional software, not an AI for diagnosis or treatment decision support.
7. The Type of Ground Truth Used
- Objective Measurements and Standard Compliance: The "ground truth" for this device's performance is based on established engineering specifications, published international standards (e.g., IEC for electrical safety, ISO for biocompatibility), and bench test results (e.g., vacuum pressure readings, cycle speeds, observing no backflow). It is not expert consensus, pathology, or outcomes data in the sense of clinical decision-making.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set of data for model development. The software is noted as having "Verification and Validation" but this refers to traditional software engineering processes, not machine learning training.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI training set, this question is not relevant. Software "ground truth" or correct functionality is established through design specifications, requirements, and traditional software testing methodologies.
In summary, the provided document is a regulatory submission for a standard medical device (an electric breast pump) that relies on non-clinical performance testing and substantial equivalence to a predicate device, not on AI/ML algorithm performance. Therefore, many of the questions related to AI evaluation criteria are not applicable.
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January 19, 2024
Guangdong Youmeng Electrical Technology Co., Ltd. % Candice Oiu Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 2401 Zhenye International Business Center, No. 3101-90. Qianhai Road Shenzhen, Guangdong 518052 China
Re: K232466
Trade/Device Name: Electric Breast Pump Model: YM-8166 Regulation Number: 21 CFR$ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: December 5, 2023 Received: December 21, 2023
Dear Candice Qiu:
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 (the 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 available 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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 mhre information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Monica D. Garcia -S
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
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Indications for Use
510(k) Number (if known) K232466
Device Name Electric Breast Pump Model: YM-8166
Indications for Use (Describe)
The Electric Breast Pump Model: YM-8166 is intended to express milk from lactating women in order to collect milk from their breasts. The device 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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K232499 510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date Prepared: January 17, 2023
I. Submitter
Guangdong Youmeng Electrical Technology Co., Ltd. One of Area A, level 3, Building 2, No. 17, Keyuan 3rd Road, Shunde Hi Tech Industrial Park, Xiaohuangpu Community, Ronggui Street, Shunde District, Foshan, Guangdong, China Post code: 528303 Tel.: +86 13567769890 Liu Zongjun General Manager Tel: +86 13567769890 Email: 223316378@qq.com
II. Device
Name of Device: Electric Breast Pump Model: YM-8166 Common or Usual Name: Powered breast pump Regulation Name: Powered breast pump Regulation Number: 21 CFR 884.5160 Regulatory Class: II Product Code: HGX (Powered, Breast, Pump)
III. Predicate Device
Predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Clearance Date |
|---|---|---|---|
| Zhejiang Carebao Co., Ltd. | Wearable Breast Pump (YD-1193, YD-1193S, YD1195, YD-1195S, YD-1196, YD-1198, YD-1199, YD-1196S, YD- 1198S, YD-1199S) | K222782 | Jan 13, 2023 |
The predicate device has not been subject to a design-related recall.
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IV. Device Description
The Electric Breast Pump Model: YM-8166 is an over-the-counter, non-sterile, single-user, powered breast pump intended to be used by lactating women to express and collect milk from their breasts. The device is intended for daily use in a home environment. The device uses a diaphragm-type vacuum pump driven by software embedded in the device to generate suction required to stimulate and express breast milk. The software provides control over vacuum pressure and cycle speed.
The following patient-contacting materials are used in the subject device:
| Componentname | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Electric BreastPump Model:YM-8166(Majoringredients) | PP & Silicone | Surface-contactingdevice: Intact skin | Less than 24 hours |
Detailed device specifications can be found in the comparison chart below.
V. Indications for Use
The Electric Breast Pump Model: YM-8166 is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
VI. Comparison of Technological Characteristics with the Predicate Device
The table below compares the intended use and technological characteristic of the subject and predicate device.
| ComparisonElements | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| 510(k) Number | K232499 | K222782 | / |
| Trade name | Electric Breast PumpModel: YM-8166 | Wearable Breast Pump(YD-1193, YD-1193S,YD1195, YD-1195S, YD-1196 YD-1198 YD-1199) | / |
| ComparisonElements | Subject Device | Predicate Device | Remark |
| YD-1196S, YD- 1198S, YD-1199S) | |||
| Manufacturer | Guangdong YoumengElectrical TechnologyCo., Ltd. | Zhejiang Carebao Co., Ltd. | / |
| Regulation number | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Product code | HGX | HGX | Same |
| Deviceclassification | Class II | Class II | Same |
| Indication for use/Intended use | The Electric BreastPump Model: YM-8166is intended to expressmilk from lactatingwomen in order tocollect milk from theirbreasts. The device isintended for a singleuser. | The Wearable Breast Pump isintended to express milk fromlactating women in order tocollect milk from theirbreasts. The device isintended for a single user. | Same |
| Prescription orOTC | OTC | OTC | Same |
| Pump Options | Single, Double | Single | Different |
| Provide Non-sterile | Yes | Yes | Same |
| Re-usable | Yes | Yes | Same |
| Direct user contact | Yes | Yes | Same |
| BackflowProtection | Yes | Yes | Same |
| Suction Modes | Stimulation Mode,Expression Mode,Pseudo-true ExpressionMode, Array Mode,and Single/double | Stimulation Mode andExpression ModeMixed Mode | Different |
| ComparisonElements | Subject Device | Predicate Device | Remark |
| Pumping Mode | |||
| Suction levels | 16 | 9 | Different |
| Adjustable suctionlevels | Yes | Yes | Same |
| Vacuum range:Stimulation mode | 60-165±20 (mmHg) | YD-1193,YD -1193S, YD-1195,YD-1195S: 36 mmHgto 241 mmHgYD-1196,YD-1198, YD-1199, YD-1196S, YD-1198S, YD-1199S: 37 mmHgto 242 mmHg | Similar |
| Vacuum range:Expression mode | 85-280±20 (mmHg) | YD-1193,YD -1193S, YD-1195,YD-1195S: 69 mmHgto 282 mmHgYD-1196,YD-1198, YD-1199, YD-1196S, YD-1198S, YD-1199S: 71 mmHgto 282 mmHg | Similar |
| Cycle Speed:Stimulation | Single Suction: 66 to138±5 cycles/minuteDouble suction: 64 to180±5 cycles/minute | 37.5 to 150 cycles/minute | Different |
| Cycle Speed:Expression | Single Suction: 32 to112±5 cycles/minuteDouble suction:28 to132±5 cycles/minute | YD-1193,YD -1193S, YD-1195,YD-1195S: 23 to 72cycles/minuteYD-1196, YD-1198, YD-1199, YD-1196S, YD-1198S, YD-1199S: 24 to 69cycles/minute | Different |
| Controls | Power button;Modeadjustmentbutton;Vacuum level increase/ | On/Off button; Modeselection Increase/decreasevacuum button; | Similar |
| ComparisonElements | Subject Device | Predicate Device | Remark |
| decrease button;Night light button(optional) ;Single/ double pumpingchange button | |||
| Indicator | Yes. General display | Yes. LED | Same |
| Power Supply | USB connector (Onlyfor charging) by DC 5V, 2 A | Li-Ion Battery (internallypowered by 3.7Vdc lithiumbattery or externally poweredby 5Vdc USB.) | Same |
| Materials | Milk collection bottle:PP and PPSU(Optional)Breast shield: SiliconerubberPump unit: ABS and PC | Milk Container:PolypropyleneFlange: Silicone Pump OuterHousing: AcrylonitrileButadiene Styrene (ABS)plastic | Same |
| Software/Firmware/MicroprocessorControl? | Yes | Yes | Same |
| Electrical safety | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 62133-2 | AAMI ANSI ES60601-1:2005/(R)2012 and A1:2012IEC 60601-1-2IEC 60601-1-11IEC 62133-2 | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10ISO 10993-23 | ISO 10993-5ISO 10993-10 | Same |
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The Electric Breast Pump Model: YM-8166 has the same intended use, mode of action and similar operational characteristics as the predicate device. The subject device differs from the predicate device in suction modes, strength, and levels, cycle speed, and a double pumping option. The different technological characteristics between the subject device and the predicate device do not raise different questions of safety and effectiveness.
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VII.Summary of Non-Clinical Performance Testing
1) Biocompatibility Testing
The biocompatibility evaluation for the patient-contacting components of the Electric Breast Pump Model: YM-8166 was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as follows:
-
ISO 10993-5:2009. Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
-
ISO 10993-23:2021, Biological evaluation of medical devices -Part 23: Tests for skin irritation
The patient-contacting components of the subject device were shown to be non-cytotoxic, nonirritating, and non-sensitizing.
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed per the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-11 Medical Electrical Equipment -Part 1: 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 62133-2 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 - Part 2: Lithium systems
3) Software Verification and Validation
Software verification and validation consistent with a basic level of concern per the FDA guidance document "Content of Premarket Submissions for Device Software Functions" dated June 14, 2023. System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met, and all software hazards have been mitigated to acceptable risk levels.
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4) Additional Non-Clinical Testing
Suction strength and cycle speed of subject devices were tested. All the test results complied with the design specifications of the subject device throughout the use life.
Backflow testing was conducted to ensure that no liquid will backflow into the tubing, and therefore no liquid can backflow into the pump motor. The test results showed that there was no backflow during the test.
Battery performance testing was conducted to demonstrate that the battery remains functional during its stated use-life.
Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.
VIII. Conclusions
The results of the performance testing described above demonstrate that the Electric Breast Pump Model: YM-8166 is as safe and 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).