(223 days)
The electric breast pump is to express and collect milk from 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. The device is intended for single user.
The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are designed and manufactured by the Shantou Xinghe Electrical Apparatus Co., Ltd. It is intended to express and collect milk from a lactating woman's breast. This action helps to alleviate engorgement of the breast, maintain the woman's ability to lactate, and provide a mother's milk for future feedings when separation of the mother and baby occur. Two models of this device, Horigen, XN- 2203H2 and Droplet, XN-2203H4, are included in this Premarket Notification submission. The primary differences between the two models, Horigen XN- 2203H2 and Droplet, XN-2203H4 are the shape of the breast shield and the settings of the stimulating velocity, stimulating intensity, sucking velocity and sucking intensity. The specific settings are listing under the summary of non-clinical tests. The product uses a Single-Chip Microcomputer to imitate a baby's suckling action. The device is ergometrically designed to create comfortable milk stimulation, massage, and suction from the breast. Three (3) stimulation levels and five (5) speeds are available to imitate the rhythm and action of a baby's suckling. The control panel is soft and viewing is provided by a LCD screen. Once programmed, the pump's electronic memory stores the selected rhythm. The Electric Breast Pump, model Horigen, XN-2203H2 and model Droplet, XN2203H4 are designed to mechanically interface with a mother's breast via a breast shield and withdraw, then collect, the breast milk. The device is driven by a microcomputer which electrically controls piston components. The pistons perform a reciprocating movement in the device cylinder and pump seat. A breast cup is fixed between the piston and the piston head on which negative and positive pressure is created by the piston action. A mobile magnet detects the mechanical movement and creates an electrical signal to the microcontroller.
The provided text describes a 510(k) Summary for an electric breast pump, models Horigen XN-2203H2 and Droplet XN-2203H4. The summary details the device's description, intended use, technology, and a comparison to a predicate device to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "acceptance criteria of performance testing" and reports the specifications for the proposed devices.
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Direct) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Performance | To perform "Stimulation, suction and collection" as well as the predicate device. | Model Droplet XN-2203H4:- Stimulating velocity: 88 T/min- Stimulating intensity: -0.018 MPa (Max.), 3 adjustable degrees- Sucking intensity: -0.028 MPa (Max.), 5 adjustable degrees- Sucking velocity: 34-63 T/min, 5 adjustable speedsModel Horigen XN-2203H2:- Stimulating velocity: 90 T/min- Stimulating intensity: -0.012 MPa (Max.), 3 adjustable degrees- Sucking intensity: -0.024 MPa (Max.), 5 adjustable degrees- Sucking velocity: 35-63 T/min, 5 adjustable speeds |
| Biocompatibility | Not cytotoxic, irritating, or a dermal sensitizer (met "FDA food additive criteria as set forth in 21 Code of Federal Regulations Part 176, 177 and 178"). | "Not cytotoxic, irritating or a dermal sensitizer" (implied to meet the criteria mentioned for predicate device). |
| Electrical Safety | Meets IEC 60601-1-2. | "Meets IEC 60601-1-2." (Specific edition not elaborated for the proposed device, but stated in the standards met section as IEC 60601-1, 3rd Edition and IEC 60601-1-2 Edition 3:2007-03) |
| EMC (Electromagnetic Compatibility) | Meets IEC 60601-1-2. | "Meets IEC 60601-1-2." (Specific edition not elaborated for the proposed device, but stated in the standards met section as IEC 60601-1, 3rd Edition and IEC 60601-1-2 Edition 3:2007-03) |
| Suction Level | Comparable to predicate device (Predicate: 30-250, Proposed: 180 maximum). | Suction level met (specific range is 180 maximum, which is considered "similar" to the predicate, with the discussion that the lower maximum vacuum range of the proposed device "would not involve any harm"). |
| Cycle Time | Comparable to predicate device (Predicate: 30-80, Proposed: 90 maximum). | Cycle time met (specific range is 90 maximum, considered "similar" to the predicate). |
| Standards Met | IEC 60601-1; IEC 60601-1-2; ISO 10993-1; ISO 10993-5; ISO 10993-10 | All listed standards were met, specifically: IEC 60601-1, 3rd Edition; IEC 60601-1-2 Edition 3:2007-03; ISO 10993-1:Fourth Edition 2009-10-15; ISO 10993-5:2009; ISO 10993-10;Third Edition 2010-08-01. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The sponsor has performed bench testing to demonstrate the electric breast pump performs within specifications." It does not specify a "test set" in terms of subject data (e.g., lactating women). The testing appears to be purely bench testing (laboratory-based performance measurements). Therefore, sample size for a test set of human subjects is not applicable/not provided. The "data provenance" is implied to be from the manufacturer's internal testing. There is no mention of country of origin for any human data or whether it was retrospective or prospective, as no human data appears to have been used in the performance testing described.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since the performance testing described is bench testing of physical parameters, there were no human experts used to establish ground truth for a clinical test set. The "ground truth" for the bench tests would be the established engineering specifications and international standards.
4. Adjudication Method for the Test Set
As no human experts or clinical test set are described, an adjudication method is not applicable/not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is bench testing of a physical device against technical specifications and a predicate device. This type of study is not relevant for evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not directly applicable. The device is an electric breast pump, a mechanical and electrical device, not an AI algorithm. Its performance is inherent to its design and function. The "standalone" performance here refers to the device operating on its own as designed, which is what the bench tests demonstrate. There is no AI component to evaluate for standalone performance in the context of typical AI device submissions.
7. The Type of Ground Truth Used
The ground truth used for the performance evaluation consists of:
- Engineering Specifications: The defined operating parameters for stimulating velocity, stimulating intensity, sucking intensity, and sucking velocity for both models.
- International Standards: Compliance with ISO 10993 (biocompatibility), IEC 60601-1 (general safety), and IEC 60601-1-2 (electrical safety/EMC).
- Comparison to Predicate Device: The performance parameters (vacuum range, cycle speed) were benchmarked against the predicate device (Ameda Platinum electric breast pump, K100435) to demonstrate substantial equivalence, implying that the predicate's established performance serves as a ground truth for comparison.
8. The Sample Size for the Training Set
This question is not applicable. The device is an electric breast pump, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this device.
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APR 2 4 2014
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:
2013/09/05
Submitter:
Primary Contact Person:
Jun Deng
General Manager
Shantou Xinghe Electrical Apparatuses Co., Ltd.
Shantou Xinghe Electrical Apparatuses Co., Ltd.
Tel: +86-754-83613668-866
Fax: +86-754-83843338
Secondary Contact Person:
Mike Gu
Regulatory Affairs Manager
OSMUNDA Medical Device Consulting Co., Ltd.
Tel: (+86)-20-6232 1333
Fax: (+86) -20-8633 0253
Device:
Trade Name: Horigen, Model XN-2203H2 and Droplet, Model XN-2203H4
Common/Usual Name:
Classification Names:
Regulation Number:
Product Code:
Powered breast pump
Powered breast pump
CFR 884.5160
HGX
Predicate Device(s):
K100435, Ameda Platinum electric breast pump
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| Device Description: | The Electric Breast Pump, model Horigen, XN-2203H2and model Droplet, XN2203H4 are designed andmanufactured by the Shantou Xinghe ElectricalApparatus Co., Ltd. It is intended to express and collectmilk from a lactating woman's breast. This action helpsto alleviate engorgement of the breast, maintain thewoman's ability to lactate, and provide a mother's milkfor future feedings when separation of the mother andbaby occur. Two models of this device, Horigen, XN-2203H2 and Droplet, XN-2203H4, are included in thisPremarket Notification submission. The primarydifferences between the two models, Horigen XN-2203H2 and Droplet, XN-2203H4 are the shape of thebreast shield and the settings of the stimulatingvelocity, stimulating intensity, sucking velocity andsucking intensity. The specific settings are listing underthe summary of non-clinical tests.The product uses a Single-Chip Microcomputer toimitate a baby's suckling action. The device isergometrically designed to create comfortable milkstimulation, massage, and suction from the breast.Three (3) stimulation levels and five (5) speeds areavailable to imitate the rhythm and action of a baby'ssuckling. The control panel is soft and viewing isprovided by a LCD screen. Once programmed, thepump's electronic memory stores the selected rhythm |
|---|---|
| --------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Intended Use: | The Electric Breast Pump, model Horigen, XN-2203H2and model Droplet, XN2203H4 are used to express andcollect milk from the breast, to alleviate engorgement ofthe breast, maintain the ability of lactation, and providemother's milk for future feedings when separation ofmother and baby occurs. The device is intended forsingle user. |
|---|---|
| --------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Technology: | The Electric Breast Pump, model Horigen, XN-2203H2and model Droplet, XN2203H4 are designed tomechanically interface with a mother's breast via abreast shield and withdraw, then collect, the breastmilk. The device is driven by a microcomputer which |
|---|---|
| ------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| electrically controls piston components. The pistonsperform a reciprocating movement in the devicecylinder and pump seat. A breast cup is fixed betweenthe piston and the piston head on which negative andpositive pressure is created by the piston action. Amobile magnet detects the mechanical movement andcreates an electrical signal to the microcontroller. | |
|---|---|
| -- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Determination of Substantial Equivalence:
| Specification | Predicate Device | Proposed Device | Discussion of Differences |
|---|---|---|---|
| Device Name | Ameda PlatinumBreast Pump | Horigen,XN2203H2 andDroplet,XN2203H4 | |
| K Number | K100435 | K132882 | |
| Indications for Use | The electric breastpump is to expressand collect milkfrom the mother'sbreast, to alleviateengorgement ofthe breast,maintain theability of lactation,and providemother's milk forfuture feedingswhen separation ofmother and babyoccurs. The electricbreast pump isintended for asingle user. | The electric breastpump is to expressand collect milkfrom the mother'sbreast, to alleviateengorgement ofthe breast,maintain theability of lactation,and providemother's milk forfuture feedingswhen separation ofmother and babyoccurs. The electricbreast pump isintended for asingle user. | Same |
| Patient Population | Breastfeedingwomen | Breastfeedingwomen | Same |
| 5-40°C | 5-40°C | 5-40°C | Same |
| Pump Style | Piston | Piston | Same |
| Vacuum Range | 30-250 | 180 maximum | Similar, themaximum vacuumrange of theproposed device isless than thepredicate device |
| Specification | Predicate Device | Proposed Device | Discussion ofDifferenceswhich would notinvolve any harm. |
| Cycle Speed | 30-80 | 90 maximum | Similar |
| OverflowProtection | No | No | Same |
| Adjustable SectionLevels | Yes | Yes | Same |
| Software | Yes | Yes | Same |
| Anatomical Sites | Breast | Breast | same |
| Energy Usedand/or Delivered | ACBattery | AC | same |
| Design andMaterials | All food or humancontactcomponents aremanufacturedfrom materials thatmeet FDA foodadditive criteria asset forth in 21Code of FederalRegulations Part176, 177 and 178. | All food or humancontactcomponents aremanufacturedfrom materials thatmeet FDA foodadditive criteria asset forth in 21Code of FederalRegulations Part176, 177 and 178. | Same |
| Performance | Stimulation,suction andcollection | Stimulation,suction andcollection | Same |
| Standards Met | IEC 60601-1, 1988;Amendment 1,1991-11,Amendment 2,1995. (General)IEC 60601-1-2,(Edition 2:2001with Amendment1:2004; Edition 2.1(Edition 2:2001consolidated withAmendment1:2004)).(General)ISO 10993-1ISO 10993-5ISO 10993-10 | IEC 60601-1, 3rdEditionIEC 60601-1-2Edition 3:2007-03ISO 10993-1:Fourth Edition2009-10-15ISO 10993-5:2009ISO 10993-10;Third Edition2010-08-01 | Same |
| Biocompatibility | Not cytotoxic | Not cytotoxic | Same |
| Specification | Predicate Device | Proposed Device | Discussion of -Differences |
| irritating or adermal sensitizer | irritating or adermal sensitizer | ||
| Electrical Safety | Electromagneticcompatibility testsare provided toillustrate thatelectrical safetymeets IEC 60601-1-2. | Electromagneticcompatibility testsare provided toillustrate thatelectrical safetymeets IEC 60601-1-2. | Same |
| Mechanical Safety | Mechanical cyclingsuction regulator. | Mechanical cyclingsuction regulator. | Same |
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Summary of Non-Clinical Tests:
The sponsor has performed bench testing to demonstrate the electric breast pump performs within specifications:
Model Droplet XN-2203H4
Stimulating velocity: 88T/min
Stimulating intensity: -0.018MPa (Max.), 3 adjustable degrees Sucking intensity: -0.028MPa (Max.), 5 adjustable degrees Sucking velocity: 34-63T/min, 5 adjustable speeds;
Model Horigen XN-2203H2
Stimulating velocity: 90T/min
Stimulating intensity: -0.012MPa (Max.), 3 adjustable degrees Sucking intensity: -0.024MPa (Max.), 5 adjustable degrees Sucking velocity: 35-63T/min, 5 adjustable speeds;
The proposed device has met acceptance criteria of performance testing including: biocompatibility (InVivo cytotoxicity, irritation, and sensitization testing) and electrical safety, EMC, and suction level and cycle time.
Conclusion:
Shountou Xinghe Electrical Apparatuses Co. Ltd. considers the electric breast pump to be as safe, as effective, and performance is substantially equivalent to the predicate device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2014
Shantou Xinghe Electrical Apparatuses Co., Ltd. Jun Deng General Manager NO.8, Yi Road, Pingbei Industrial Zone, Chaoyang District Shantou, Guangdong 515100 China
Re: K132882
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 25, 2014 Received: March 27, 2014
Dear Jun Deng,
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. 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.
:
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Page 2 - Jun Deng
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K132882
Device Name
Electric breast pump
Indications for Use (Describe)
The electric breast pump is to express and collect milk from 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. The device is intended for 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
MENT SERVICE MARK STORE FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Herbert P. Lerner -S 2014.04.24 11:15:43 -04
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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).