(80 days)
The Momcozy Wearable Electric Breast Pump (Model: S9 Pro, S12 Pro) is a powered breast pump intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
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This document is an FDA 510(k) clearance letter for the Momcozy Wearable Electric Breast Pump. Unfortunately, it does not contain the detailed information required to answer your specific questions regarding acceptance criteria and the study that proves the device meets them.
The FDA 510(k) clearance process primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive performance studies with detailed acceptance criteria as one might see for novel AI/ML medical devices or higher-risk devices.
Here's why the document doesn't have the information you're looking for, and generally, what a 510(k) submission for a non-AI/ML device typically entails:
- Acceptance Criteria and Device Performance Table: This type of table is not part of a standard 510(k) clearance letter for a powered breast pump. A 510(k) submission might include performance testing data (e.g., motor strength, suction levels, battery life, biocompatibility), but this data is usually summarized in the submission itself, not in the clearance letter. The FDA clears the device based on the sponsor demonstrating that these performance characteristics are substantially equivalent to the predicate device, not necessarily against pre-defined clinical acceptance criteria for an AI algorithm.
- Sample Size and Data Provenance for Test Set: Not applicable in the context of this 510(k) clearance letter. There isn't a "test set" in the sense of clinical image data for an AI algorithm. Performance testing for a breast pump would involve engineering tests (e.g., measuring suction, flow rate) rather than clinical studies with patient data.
- Number of Experts, Ground Truth, Adjudication, MRMC Study, Standalone Performance: These concepts are relevant to AI/ML device evaluations. A breast pump is a mechanical device, not an AI algorithm. Therefore, none of these aspects would be part of its 510(k) submission or clearance.
- Type of Ground Truth: For a breast pump, "ground truth" would relate to its physical performance metrics (e.g., milk expression efficiency, comfort), which are assessed through engineering tests and user feedback, not expert consensus on medical images or pathology.
- Sample Size for Training Set & Ground Truth for Training Set: These are concepts specific to AI/ML model development. A breast pump does not have a "training set" in this context.
In summary, the provided document is a regulatory clearance for a medical device (a breast pump) that is not an AI/ML device. Therefore, the detailed questions about acceptance criteria, study design, and ground truth for AI model validation do not apply to this specific document or the type of device it describes.
To find the kind of information you are asking for, you would need to look at FDA clearance documents and associated summaries for AI/ML-enabled medical devices. These documents, particularly the Decision Summary (or Summary of Safety and Effectiveness), often detail the clinical study information, validation methods, acceptance criteria, and performance results for the AI algorithm.
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June 9, 2023
Shenzhen Lutejiacheng Technology Co., Ltd. Athena Pan General Manager #2-2, Floor 2 Hasee Computer Building, No.2 Beier Rd, Bantian Street, Longgang Shenzhen, Guangdong 518129 China
Re: K230776
Trade/Device Name: Momcozy Wearable Electric Breast Pump (Model: S9 Pro, S12 Pro) Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: March 9, 2023 Received: March 21, 2023
Dear Athena Pan:
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.
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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 (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/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.
Reginald K. Avery -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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K230776
Device Name
Momcozy Wearable Electric Breast Pump (Model: S9 Pro, S12 Pro)
Indications for Use (Describe)
The Momcozy Wearable Electric Breast Pump (Model: S9 Pro, S12 Pro) is a powered breast pump 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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§ 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).