(154 days)
Not Found
No
The summary describes a standard powered breast pump with adjustable settings and an LCD display. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, prediction, or adaptive behavior. The principle of operation is based on generating negative pressure, a mechanical process.
No
The device is a breast pump intended to express and collect milk, and its description does not mention any therapeutic claims or effects for medical treatment or diagnosis.
No
The device is a breast pump, intended to express and collect milk, not to diagnose a medical condition.
No
The device description explicitly states that the OPERA & OPERA eco consist of a group of hardware and software components, and lists several hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breasts of lactating women." This is a physical process performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a mechanical pump that generates negative pressure. It does not describe any components or processes related to analyzing biological samples.
- Principle and Theory of Operation: The operation involves creating vacuum and moving a diaphragm to extract milk. This is a mechanical action, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a disease or condition.
In summary, the OPERA and OPERA eco are medical devices, specifically breast pumps, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OPERA and OPERA 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 OPERA & OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women. The OPERA eco are provided non-sterile. Two models are available; Opera and Opera eco.
- "OPERA" (pink color): powered by the adapter (AD/DC adapter, INPUT: AC 100 ~240V, . 50/60Hz, OUTPUT: DC14V, 2A) or by the internal battery (Rechargeable Lithium polymer battery, 11.1 V, 2200 mAh).
- . "OPERA eco" (blue color): powered by the adapter (AD/DC adapter, INPUT: AC 100 ~240V, 50/60Hz, OUTPUT: DC14V, 2A).
The OPERA & OPERA eco consists of a group of hardware and software components. The hardware component(s) consist of:
- Opera or Opera eco pump body ●
- Breast Shield Set (Breast shield, K-POP Diaphragm, Bottle Disk, Bottle Cover, Bottle ● Cap, Bottle, Nipple, White Valve, Diaphragm, Cap, Air Tube Connector, Silicone Massager)
- Adaptor
The OPERA & OPERA eco provide the following user features:
-
- Two Modes
- Massage Mode: 5 Levels
- Expression Mode: 8 Levels
-
- Adjustment of vacuum level/cycles
-
- LCD Display, for user assistance/device status
Principle and Theory of Operation:
The Opera and Opera eco generate negative pressure on the breast and it moves diaphragm up and down to express and collect milk from the breasts of lactating women. To prevent backflow of breastmilk, Opera & Opera eco include a backflow protector on the top of breast shield. The inserted diaphragm blocks the upper side and bottom side of breast shield, which are the pathway of air and the breastmilk.
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
Hospital, Home environment
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 performance data were provided in support of the substantial equivalence determination:
- Electrical Safety, Electromagnetic Compatibility and Performance:
The OPERA & OPERA eco comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AM1:2012
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014 ●
- Medical electrical equipment and medical electrical systems used in the home healthcare environment . in accordance with IEC 60601-1-11:2015
- Software Validation
The OPERA & OPERA eco have a MODERATE level of concern. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance:
- "The content of premarket submissions for software contained in medical devices, published on May ● 11, 2005"
-
Biocompatibility
The OPERA & OPERA eco were assessed for biocompatibility per ISO 10993. -
Performance testing
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.
Conclusion:
The performance testing demonstrate that the OPERA eco (K190810) are substantially equivalent to the predicate device, MINUET LCD, MINUET LCD eco (K180075).
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
August 30, 2019
Unimom Co. Sang-Hyun Hong President 110-19, Gajangsaneopseobuk-ro Osan-si, 18102 Gyeongg1-do KOREA
Re: K190810 Trade/Device Name: OPERA, OPERA eco Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II
Product Code: HGX Dated: July 22, 2019 Received: July 29, 2019
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.
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
1
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,
Sharon M. Andrews Assistant Division 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
2
Indications for Use
510(k) Number (if known)
Device Name OPERA & OPERA eco
Indications for Use (Describe)
The OPERA and OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
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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3
510(k) Summary – K190810 [As Required by 21 CFR 807.92]
Submitter's Information
| Submitter's Name: | Unimom Co. |
|---|---|
| Address: | 110-19, Gajangsaneopseobuk-ro, Osan-si, |
| Gyeonggi-do, 18102, KOREA [Zip.18102] | |
| Contact Person: | Hong, Sang-Hyun |
| Telephone No.: | +82-70-8798-5577 |
| Fax No.: | +82-31-372-6782 |
| Email Address: | infounimom@naver.com |
Date Prepared
August 29, 2019
Trade Name, Regulation Name, Classification
| Trade/Device Name | OPERA & OPERA eco |
|---|---|
| Common Name | Powered breast pump |
| Classification Number | 21 CFR 884. 5160 |
| Classification Name | Powered breast pump |
| Regulation Class | Class II |
| Product Code | HGX |
| Product Code Name | Pump, Breast, Powered |
Identification of Predicate Device
The identified predicate devices within this submission are shown as follow;
| 510(k) Number: | K180075 |
|---|---|
| Applicant: | Unimom Co. |
| Trade/Device Name: | MINUET LCD, MINUET LCD eco |
| Classification Number: | 21 CFR 884. 5160 |
| Classification Name: | Powered breast pump |
| Regulation Class: | Class II |
| Product Code: | HGX |
4
Product Code Name:
Pump, Breast, Powered
The predicate device has not been subject to a design-related recall.
Description of the Device
The OPERA & OPERA eco are multiple-user. powered breast pumps intended to express and collect milk from the breasts of lactating women. The OPERA eco are provided non-sterile. Two models are available; Opera and Opera eco.
- "OPERA" (pink color): powered by the adapter (AD/DC adapter, INPUT: AC 100 ~240V, . 50/60Hz, OUTPUT: DC14V, 2A) or by the internal battery (Rechargeable Lithium polymer battery, 11.1 V, 2200 mAh).
- . "OPERA eco" (blue color): powered by the adapter (AD/DC adapter, INPUT: AC 100 ~240V, 50/60Hz, OUTPUT: DC14V, 2A).
The OPERA & OPERA eco consists of a group of hardware and software components. The hardware component(s) consist of:
- Opera or Opera eco pump body ●
- Breast Shield Set (Breast shield, K-POP Diaphragm, Bottle Disk, Bottle Cover, Bottle ● Cap, Bottle, Nipple, White Valve, Diaphragm Cap, Air Tube Connector, Silicone Massager)
- Adaptor
The OPERA & OPERA eco provide the following user features:
-
- Two Modes
- Massage Mode: 5 Levels
- Expression Mode: 8 Levels
-
- Adjustment of vacuum level/cycles
-
- LCD Display, for user assistance/device status
Principle and Theory of Operation:
The Opera and Opera eco generate negative pressure on the breast and it moves diaphragm up and down to express and collect milk from the breasts of lactating women. To prevent backflow of breastmilk, Opera & Opera eco include a backflow protector on the top of breast shield. The inserted diaphragm blocks the upper side and bottom side of breast shield, which are the pathway of air and the breastmilk.
Indications for Use
The OPERA & OPERA eco are multiple-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.
5
Substantial Equivalence Comparison
subject and predicate devices.
| Proposed Device | Predicate Device | |
|---|---|---|
| Product Name | OPERA, OPERA eco | MINUET LCD, MINUET LCD eco |
| 510(k) Number | Not known | K180075 |
| Manufacturer | Unimom Co. | Unimom Co. |
| Product Code | HGX | HGX |
| Device Class | II | II |
| Indications for Use | The OPERA & OPERA eco are multiple- user, powered breast pumps intended to express and collect milk from the breasts of lactating women. | 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. |
| Intended use environment | Hospital, Home environment | Hospital, Home environment |
| Specifications | ||
| Power source (Adapter) | AC/DC Adapter |
- Rated input: AC 100~240V, 50/60Hz
- Rated output: DC14V, 2A | AC/DC Adapter with Micro USB Cable
- Rated input: AC 100~240V, 50/60Hz
- Rated output: 5Vdc, 2A |
| Power source (Battery) | Rechargeable Lithium Polymer Battery (Only for OPERA) | Rechargeable Lithium Polymer Battery (Only for MINUET LCD) |
| Pump type | Diaphragm | Diaphragm |
| Pump Options | Single or Double | Single or Double |
| Mode | 2 Modes
(Massage Mode, Expression Mode) | 2 Modes
(Massage Mode, Expression Mode) |
| Vacuum Levels | Massage Mode: 5 Levels Expression Mode: 8 Levels | Massage Mode: 7 Levels Expression Mode: 9 Levels |
| Vacuum Strength | 45 - 280 mmHg | 50 - 280 mmHg |
| Cycle Range | Massage Mode
: 60 – 100 cycles/min
Expression Mode
: 26 - 42 cycles / min | Massage Mode
: 23 – 120 cycles/min
Expression Mode
: 13 - 60 cycles / min |
| User Interface | Switch control - Power, Vacuum / Cycle Up or Down
- Mode switch
LCD Display | Switch control - Power, Vacuum / Cycle Up or Down
- Mode switch
LCD Display |
| Accessories | Air Tube
Breast Shield Kit with back-flow protector
Bottle
Bottle Cover
Nipple
Bottle Cap
Bottle Disk
Bottle Stand
Adapter
Air Tube Connector
Silicone Massager | Air Tube
Breast Shield Kit with back-flow protector
Bottle
Bottle Cover
Nipple
Bottle Cap
Bottle Disk
Bottle Stand
Adapter
B-Connector
Micro USB Cable
Silicone Massager
Micro USB Jack Cover |
| Backflow Protection | Yes
(Milk is prevented from entering the tubing) | Yes
(Milk is prevented from entering the tubing) |
| Proposed Device | Predicate Device | |
| Wipe with clean, damp cloth - Breast Shield Kit: Boiling water | Wipe with clean, damp cloth
- Breast Shield Kit: Boiling water | |
6
The indications for use statement of the subject device is unchanged from the predicate device; accordingly, the subject and predicate device have the same intended use. The subject and predicate device have similar technological characteristics, and the differences in technological characteristics do not raise different questions of safety or effectiveness.
Summary of Performance Testing
The following performance data were provided in support of the substantial equivalence determination:
- Electrical Safety, Electromagnetic Compatibility and Performance:
The OPERA & OPERA eco comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AM1:2012
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2014 ●
- Medical electrical equipment and medical electrical systems used in the home healthcare environment . in accordance with IEC 60601-1-11:2015
2) Software Validation
The OPERA & OPERA eco have a MODERATE level of concern. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance:
- "The content of premarket submissions for software contained in medical devices, published on May ● 11, 2005"
3) Biocompatibility
The OPERA & OPERA eco were assessed for biocompatibility per ISO 10993.
4) Performance testing
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.
Conclusion
The performance testing demonstrate that the OPERA eco (K190810) are substantially equivalent to the predicate device, MINUET LCD, MINUET LCD eco (K180075).