(188 days)
The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are powered breast pumps to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.
The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are single-user powered breast pumps capable of single pumping. The subject devices are powered by a rechargeable lithium ion battery or AC adapter. They are non-sterile. The powered breast pumps' drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over vacuum pressure and cycle speed.
Models YY-A11, YY-A21 and YY-A41 are capable of single pumping and have two modes:
- Massage mode: Helps to relax the muscle around the breast and prepare for suction.
- Normal mode: Suction patterns are characterized by low vacuum to start milk flow.
In addition to the two modes described above, Models YY-A31, YY-A103, YY-A103, YY-A104, and BF103 are capable of single pumping and have an additional mode:
- Rapid mode: Suction patterns are characterized by high vacuum to express more milk.
Model BF100 is capable of single and double pumping and has two modes only:
- Letdown mode: Helps to relax the muscle around the breast and prepare for suction.
- Expression mode: Suction patterns are characterized by high vacuum to express more milk.
This document is a 510(k) summary for a powered breast pump (Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump). It describes testing conducted to demonstrate substantial equivalence to a predicate device, but it does not provide acceptance criteria or detailed study results in the format requested for an AI model evaluation.
Therefore, I cannot extract the specific information about acceptance criteria and study detailed performance as per your request because it is not present in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical testing against industry standards, rather than reporting device performance against specific, quantifiable acceptance criteria with a documented study for an AI model.
Here's what I can tell you based on the document's content regarding the type of information you requested:
- Acceptance Criteria & Reported Device Performance: This information is not explicitly provided in a table or detailed study report format. The document states that "Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate."
- Sample Size for Test Set and Data Provenance: Not applicable as this is a physical device, and the testing described is non-clinical bench testing.
- Number of Experts Used to Establish Ground Truth & Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone Performance (Algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable. The "ground truth" for this device would be its physical performance characteristics (e.g., vacuum, cycle speed) matching design specifications and industry standards.
- Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
- How Ground Truth for Training Set was Established: Not applicable.
Summary of Non-Clinical Testing Performed (as provided in the document):
The document lists the following categories of non-clinical testing performed:
- Electromagnetic Compatibility, Electrical Safety, and Battery Safety: Tested in compliance with ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 62133-2.
- Biocompatibility: Patient-contacting components were tested in compliance with ISO 10993-1, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10).
- Software Verification: Software documentation was provided in accordance with FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).
- Performance Testing (Bench testing): Conducted to demonstrate pump performance (vacuum performance, speed verification, milk collection in worst-case scenario), battery performance, backflow protection, and overflow protection using internal test protocols.
The conclusion states that these tests demonstrate the devices are "as safe and effective as the predicate device and supports a determination of substantial equivalence." However, specific numerical performance results or explicit acceptance criteria values for these tests are not detailed in this summary.
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March 30, 2020
Guangzhou Yongyi Industrial Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou. 510000 CHINA
Re: K192640
Trade/Device Name: Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: February 25, 2020 Received: February 28, 2020
Dear Cassie Lee:
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-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 medical devices and radiation-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. Acting 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) K192640
Device Name
Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump
Indications for Use (Describe)
The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are powered breast pumps to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K192640
1. Submitter Information
| Sponsor Name: | Guangzhou Yongyi Industrial Co., Ltd. |
|---|---|
| Address: | B3, No.29, Qixin Road, Dongchong Town, Nansha District, GuangzhouGuangdong China. |
| Contact name: | Jian Zhongrong (GM) |
| Tel: | +86-020-39953345 |
| Fax: | +86-020-39953354 |
| E-mail: | diky@kidrobaby.com |
Application Correspondent:
| Contact Person: | Ms. Cassie Lee |
|---|---|
| Guangzhou GLOMED Biological Technology Co., Ltd. | |
| Address: | 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, |
| Guangzhou, Guangdong, China | |
| Tel: | +86-20-61099984 |
| Email: | regulatory@glomed-info.com |
Date summary was prepared: March 25, 2020
2. Subject Device Information
| Trade Name: | Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump |
|---|---|
| Models: | Kidro: YY-A11, YY-A21, YY-A31, YY-A41, YY-A51, YY-A103, YY-A104 |
| Dr. Brown's: BF103, BF100 | |
| Common Name: | Powered Breast Pump |
| Regulation Number: | 884.5160 |
| Product Code: | HGX (pump, breast, powered) |
| Class: | II |
| Review Panel: | Obstetrics/Gynecology |
3. Predicate Device Information
| 510(K) Number: | K181937 |
|---|---|
| Device Name: | Pump In Style® Advanced |
| Manufacturer: | Medela LLC |
The predicate device has not been subject to a design-related recall.
4. Device Description
The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are single-user powered breast pumps capable of single pumping. The subject devices are powered by a rechargeable lithium ion battery or AC adapter. They are non-sterile. The powered breast pumps' drive unit employs a diaphragm-type vacuum pump, powered by a DC-motor, supervised by a microcontroller. The microcontroller provides control over vacuum pressure and cycle speed.
Models YY-A11, YY-A21 and YY-A41 are capable of single pumping and have two modes:
- Massage mode: Helps to relax the muscle around the breast and prepare for suction. .
- . Normal mode: Suction patterns are characterized by low vacuum to start milk flow.
In addition to the two modes described above, Models YY-A31, YY-A103, YY-A103, YY-A104, and BF103 are capable of single pumping and have an additional mode:
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-
. Rapid mode: Suction patterns are characterized by high vacuum to express more milk.
Model BF100 is capable of single and double pumping and has two modes only: -
Letdown mode: Helps to relax the muscle around the breast and prepare for suction. ●
-
Expression mode: Suction patterns are characterized by high vacuum to express more milk. .
5. Indications for Use
The Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are powered breast pumps to be used by lactating women to express and collect milk from their breasts. They are intended for a single user.
6. Predicate Comparison
The following table compares the subject devices to the predicate with respect to the indications for use and technological characteristics:
| Device | Subject DeviceK192640 | Predicate DeviceK181937 |
|---|---|---|
| Company | Guangzhou Yongyi Industrial Co.,Ltd. | Medela LLC |
| Name and Model | Kidro Digital Electric Breast PumpModels: YY-A11, YY-A21, YY-A31, YY-A41, YY-A51, YY-A103, YY-A104Dr. Brown's Digital Electric Breast PumpModels: BF103, BF100 | Pump In Style® Advanced |
| 510(k) Number | K192640 | K181937 |
| Patient Population | Lactating women | Lactating women |
| Indications for Use | The Kidro Digital Electric Breast Pump and Dr.Brown's Digital Electric Breast Pump arepowered breast pumps to be used by lactatingwomen to express and collect milk from theirbreasts. They are intended for a single user. | The Pump In Style® Advancedbreast pump is a powered breastpump to be used by lactatingwomen to express and collectmilk from their breast. Thepowered breast pump isintended for a single user. |
| Environment ofUse | Home | Home |
| Single/doublepump | Single: YY-A11, YY-A21, YY-A31, YY-A41,YY-A51, YY-A103, YY- A104, BF103Double: BF100 | Single and double pumping |
| Direct user contact | Yes | Yes |
| Adjustablepumping levels | Yes | Yes |
| Visual indicator | LED: YY-A11, YY-A21, YY-A41LCD Screen: YY-A31, YY-A51, YY- A103, YY-A104, BF103, BF100 | No visual indicator |
| Maximum vacuum(mmHg) | -295 mmHg | -295 mmHg |
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| Vacuum range(mmHg) | YY-A11/YY-A21/YY-A41: -67.5 to -285mmHgYY-A31/YY-A51/YY-A103/YY-A104/BF103:-97.5 to -295mmHgBF100: -45 to -231mmHg | -50 to -240 mmHg |
|---|---|---|
| Cycle Speed | YY-A11/YYA21/YY-A41: 49-63 cycles/minYY-A31/YY-A51/YY-A103/YY-A104/BF103: 40-63 cycles/minBF100: 36-63 cycles/min | 120 cycles |
| Cycling/SuctionControl | Microprocessor | Microprocessor |
| Power Supply type | AC Adapter or rechargeable lithium battery | AC Adapter, AA batteries, orSwitching vehicle power adapter |
| Battery use life | Approx.1.5h for pumping time | Unknown |
| Low batteryindicator | Yes | Unknown |
| Automatic PowerOff | Yes | Unknown |
The subject devices have similar indications for use and the same intended use as the predicate device, As noted in the table above, the subject and predicate devices have different technological characteristics. The differences in technological characteristics do not raise different questions of safety and effectiveness.
7. Summary of Non-Clinical Testing
Non-clinical testing was conducted to verify that the subject devices met all design specifications, demonstrated safety based on current industry standards, and to demonstrate substantial equivalence to the predicate. The following tests were performed:
- a. Electromagnetic Compatibility, Electrical Safety, and Battery Safety: The subject devices were tested in compliance with the following:
- i. ANSI/AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- ii. IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- iii. IEC 60601-1-11 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
- iv. IEC 62133-2 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- ﻘ Biocompatibility: Patient contacting components were subjected to biocompatibility testing in compliance with ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation
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and testing within a risk management process, including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10).
- ﻥ Software Verification: Software documentation was provided in accordance with FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
- Performance Testing: Bench testing was conducted to demonstrate pump performance di (vacuum performance, speed verification, milk collection in the worst-case scenario), batterv performance, backflow protection, and overflow protection were tested using internal test protocols.
Conclusion 8.
The results of the performance testing described above demonstrate that the Kidro Digital Electric Breast Pump and Dr. Brown's Digital Electric Breast Pump are 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).