(208 days)
Not Found
No
The document describes a standard powered breast pump with different modes and suction levels, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is a breast pump used to express and collect milk, which is not considered a therapeutic function based on the provided information.
No
The device description states its purpose is to "express and collect milk," which is a functional purpose, not a diagnostic one.
No
The device description clearly outlines hardware components such as a control unit (pump), breast shield kit, and a rechargeable battery option, indicating it is a physical medical device with software control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Device Function: The MINUET LCD and MINUET LCD eco are breast pumps. Their function is to physically express and collect milk from the breasts. They do not analyze any biological specimens to provide diagnostic information.
- Intended Use: The intended use clearly states "to express and collect milk from the breasts of lactating women." This is a mechanical function, not a diagnostic one.
Therefore, based on the provided information, the MINUET LCD and MINUET LCD eco are not IVD devices.
N/A
Intended Use / Indications for Use
The MINUET LCD and MINUET LCD eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The MINUET LCD and MINUET LCD eco are portable, multiple-user, powered breast pumps to be used in home or health care settings. These devices are the same, except the MINUET LCD has a rechargeable battery whereas the MINUET LCD eco does not. The devices have two major components: control unit (pump) and breast shield kit (breast shield, diaphragm, tubing, silicone massager, and bottle components). Users have the option of single or double pumping. The devices have two operating modes: massage and expression. The massage mode has seven suction levels whereas the expression mode offers nine suction levels. The vacuum strength range is 50-280 mmHq.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Home or health care settings
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)
The following studies have been conducted on the subject devices to support substantial equivalence to the predicate device:
- Biocompatibility studies on the breast shield, as follows: .
- Cytotoxicity testing per 10993-5:2009 O
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010 O
- Irritation testing per ISO 10993-10:2010 O
- Electrical safety testing in accordance with: .
- IEC 60601-1:2005+ CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) O
- IEC 60601-1-11:2015 O
- Electromagnetic compatibility testing per IEC 60601-1-2:2014 .
- Battery safety testing in accordance with: .
- AAMI/ANSI ES60601-1:2005 o
- IEC 62133:2012 o
- . Software verification and validation testing in accordance with FDA quidance: "The content of premarket submissions for software contained in medical devices" dated May 11, 2005
- . Bench tests using internal test protocols to demonstrate device performance, including vacuum level settings, speed settings, backflow/cross-contamination protection, battery operation, and use-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
Predetermined 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 6, 2018
UNIMOM CO. Sang-Hyun Hong President 110-19 Gajangsaneopseobuk-ro Osan-si, Gyeonggi-do 18102 Korea
Re: K180075
Trade/Device Name: MINUET LCD, MINUET LCD eco Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: June 27, 2018 Received: July 5, 2018
Dear Sang-Hyun Hong:
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.
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 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
2
Indications for Use
510(k) Number (if known) K180075
Device Name MINUET LCD, MINUET LCD eco
Indications for Use (Describe)
The MINUET LCD and MINUET LCD eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
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 (K180075)
1. Submitter Information
| Submitter: | UNIMOM CO. |
|---|---|
| Address: | 110-19, Gajangsaneopseobuk-ro, Osan-si, |
| Gyeonggi-do, 18102, KOREA | |
| Contact Name: | Hong, Sang-Hyun |
| Telephone: | +82-70-8798-5577 |
| Fax: | +82-31-372-6782 |
| infounimom@naver.com |
2. Date Prepared: August 3, 2018
3. Device Information
| Trade/Device Name | MINUET LCD, MINUET LCD eco |
|---|---|
| Common Name | Powered breast pump |
| Regulation Number | 21 CFR 884.5160 |
| Regulation Name | Powered Breast Pump |
| Product Code | HGX (Pump, Breast, Powered) |
| Regulatory Class | II |
4. Predicate Device
Spectra S1 Plus and Spectra S2 Plus (K150476) manufactured by Uzinmedicare Co. The predicate device has not been subject to any design related recalls.
5. Device Description
The MINUET LCD and MINUET LCD eco are portable, multiple-user, powered breast pumps to be used in home or health care settings. These devices are the same, except the MINUET LCD has a rechargeable battery whereas the MINUET LCD eco does not. The devices have two major components: control unit (pump) and breast shield kit (breast shield, diaphragm, tubing, silicone massager, and bottle components). Users have the option of single or double pumping. The devices have two operating modes: massage and expression. The massage mode has seven suction levels whereas the expression mode offers nine suction levels. The vacuum strength range is 50-280 mmHq.
6. Indications for Use
The MINUET LCD and MINUET LCD eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
4
7. Comparison of Intended Use and Technological Characteristics of the Subject Device and Predicate Device
| Devices | K180075 (subject devices) | K150476 (predicate device) |
|---|---|---|
| Indications for Use | The MINUET LCD and MINUET LCD | |
| eco are multiple-user, powered breast | ||
| pumps intended to express and | ||
| collect milk from the breasts of | ||
| lactating women. | The Spectra S1 Plus and Spectra S2 Plus | |
| are single-user, powered breast pumps | ||
| intended to express and collect milk from | ||
| the breasts of lactating women. | ||
| Pump type | Same as the predicate | Diaphragm |
| Vacuum strength | Same as the predicate | 50-280 mmHg |
| Suction level | Massage Mode: 7 levels | Massage Mode: 5 levels |
| Suction level | Expression Mode: 9 Levels | Expression Mode: 12 Levels |
| Cycle speed | Massage Mode: 23-120 cycles/min | |
| Expression Mode: 13-60 cycles/min | 38-70 cycles/min | |
| Back flow protection | Same as the predicate | Backflow protector (diaphragm) on the top |
| of milk collection assembly | ||
| Visual indicator | Same as the predicate | LCD |
| Software control | Same as the predicate | Yes |
| Power supply - Mains | AC/DC adapter with micro USB cable | AC/DC converter |
| Power supply - Battery | Same as the predicate | Rechargeable lithium ion battery |
| Pump option | Same as the predicate | Single or double |
The subject and predicate devices have intended use – expressing mill from the breasts of lactating women. They also use the same fundamental technoloqy - a microprocessor-controlled diaphragm pump and a solenoid. They have the same vacuum strength range, backflow prevention mechanism, and pump options. They also have comparable power supplies.
The subject and predicate devices have different technological characteristics, as they have different suction levels under each operational mode. Also, the subject devices have high cycle speed up to 120 cycles/min under massage mode. These differences between the subject and predicate devices do not raise different questions of safety and effectiveness.
8. Summary of Non-Clinical Performance Testing
The following studies have been conducted on the subject devices to support substantial equivalence to the predicate device:
- Biocompatibility studies on the breast shield, as follows: .
- Cytotoxicity testing per 10993-5:2009 O
- Guinea Pig Maximization Sensitization testing per ISO 10993-10:2010 O
- Irritation testing per ISO 10993-10:2010 O
- Electrical safety testing in accordance with: .
- IEC 60601-1:2005+ CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) O
- IEC 60601-1-11:2015 O
5
- Electromagnetic compatibility testing per IEC 60601-1-2:2014 .
- Battery safety testing in accordance with: .
- AAMI/ANSI ES60601-1:2005 o
- IEC 62133:2012 o
- . Software verification and validation testing in accordance with FDA quidance: "The content of premarket submissions for software contained in medical devices" dated May 11, 2005
- . Bench tests using internal test protocols to demonstrate device performance, including vacuum level settings, speed settings, backflow/cross-contamination protection, battery operation, and use-life
9. Conclusion
The subject and predicate devices have the same intended use. Although there are differences in technological characteristics between the subject and predicate devices, these differences do not raise different questions of safety or effectiveness. The performance data demonstrate that the subject devices are substantially equivalent to the predicate device.