(271 days)
Not Found
No
The document describes a standard powered breast pump with pre-programmed modes and adjustable vacuum levels. There is no mention of AI, ML, or any learning or adaptive capabilities based on user input or data. The performance studies focus on electrical safety, software validation (standard for medical devices), biocompatibility, and bench performance testing of vacuum and cycle rate.
No
A breast pump is intended to express and collect milk, which is not considered a therapeutic function.
No
Explanation: The Spectra Q is a breast pump used to express and collect milk, as stated in the 'Intended Use / Indications for Use' and 'Device Description' sections. It facilitates a physiological process rather than diagnosing a medical condition.
No
The device description explicitly lists multiple hardware components including the pump, breast shields, tubing, bottles, and power adapters.
Based on the provided information, the Spectra Q breast pump is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from their breasts." 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 and accessories for milk collection. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices typically involve reagents, test strips, or analytical components used to examine samples like blood, urine, or tissue. The Spectra Q does not have these characteristics.
- Performance Studies: The performance studies focus on electrical safety, software validation, biocompatibility, and bench performance related to vacuum levels and cycle rates – all relevant to a physical medical device, not an IVD.
Therefore, the Spectra Q breast pump is classified as a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Spectra Q is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Q is intended for home use by a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Spectra Q breast pump is comprised of a Spectra Q pump, breast shield (20, 24, 28, 32 mm), backflow protector, silicone valve, tubing, bottles (including the nipple, cap, cover, and disk), 2-wav connector (for double pumping), and power adapters. The breast pump is provided with one 24 mm and one 28 mm breast shield. Optional components include a small cap converter, assembled with the feeding bottle, the 20 and 32 mm breast shields, and a wide bottle stand.
The Spectra Q breast pump is used by lactating women to express and collect milk from their breasts. The pump is intended for home use by a single user. Pumping with the Spectra Q breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).
The Spectra O breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -50 to -270 mmHq with cycle rates up to 110 cycles per minute. The device is powered by a 6 V AC/DC power adapter or a 5 V USB C type power adapter. Device specification are listed in Section 7 below. The device is provided non-sterile.
The Spectra Q provides the following user features:
- Five LED indicators for vacuum levels .
- Four buttons for adjustment of on/off, selection of mode, decrease vacuum, and increase ● vacuum
- Massage Mode: pumping pattern with lower vacuum levels and higher cvcle speeds. The ● indicator lights are flickering when operating in massage mode.
- Expression Mode: pumping pattern with higher vacuum levels and lower cycle speeds. The indicator lights are solid when operating in expression mode.
- Option of either single or double (dual) breast pumping
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
lactating women; home use
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)
Summary of Non-Clinical Tests:
The Spectra Q complies with voluntary standards for electrical safety, electromagnetic compatibility, and use in the home healthcare environment.
Electrical Safety/Electromagnetic Compatibility:
Testing in accordance with the following standards:
- AAMI / ANSI ES60601-1:2005/A1:2012, Medical Electrical Equipment: Part 1: General . Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements for Basic . Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
- IEC 60601-1-11:2015, 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 Environment2) Software Validation
Software Validation:
Software/firmware verification and validation were provided in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Biocompatibility:
Biocompatibility evaluation was completed according to the FDA quidance "Use of International Standard ISO- 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," dated June 16, 2016, and concluded that no new testing was required, as all patient-contacting materials are identical to those used in the predicate device (K162415). Milk-contacting components were identified and were compliant with appropriate food-contacting regulations (21 CFR 177.1520).
Bench Performance Testing:
Bench performance testing was conducted with internal test protocols to confirm the minimum and maximum vacuum levels of the pump, as well as cycle rate, meets the listed specifications. The specifications were met for all vacuum levels and cycle rates, for single and double pumping with both power sources (AC/DC wall adapter and USB C adapter). Pump use life testing was conducted to demonstrate the device maintains its specifications throughout its use life under all power sources and worst-case cycle parameters.
Key results: The performance data demonstrate the subject device is substantially equivalent to the predicate device.
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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
January 22, 2020
Uzinmedicare Co. % Dogyun Im Senior Researcher GMS Consulting Co., Ltd. 34, Sangamsan-ro, Mapo-gu, Seoul, Republic of Korea Seoul-si.Mapo-gu 03909 KOREA, REPUBLIC OF
Re: K191109
Trade/Device Name: Spectra Q Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: April 23, 2019 Received: April 26, 2019
Dear Dogyun Im:
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,
Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastrorRenal, 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) K191109
Device Name Spectra Q
Indications for Use (Describe)
The Spectra Q is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Q is intended for home use by 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary - K191109
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(1)]
January 21, 2020
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Name of Manufacturer: | Uzinmedicare Co. |
|---|---|
| Address: | 1) Rm 105, Joongang Induspia V, Sagimakgolo 137, |
| Jungwon-gu, Seongnam-Si, Gyeonggi-do, 13202, South Korea |
-
56 Dongtansandan 5-gil, Dongtan-myeon, Hwaseong-si,
Gyeonggi-do, 18487, South Korea |
| Contact Name: | JISUN LEE |
| Telephone No.: | 1) +82-31-739-5271 -
+82-31-375-1076 |
| Fax No.: | 1) +82-31-739-5269 -
+82-31-375-1079 |
| Email Address: | zsuny@uzinmedical.co.kr |
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Trade/Device Name | Spectra Q |
|---|---|
| Regulation Name | Powered breast pump |
| Regulation Number | 21 CFR 884. 5160 |
| Common Name | Powered breast pump |
| Product Code | HGX (Pump, Breast, Powered) |
| Regulatory Class | Class II |
4
4. Identification of Predicate Device [21 CFR 807.92(a)(3)]
- 510(k) Number: K162415
- Applicant: ● Uzinmedicare Co.
- . Trade/Device Name: Spectra 9Plus
The predicate device has not been subject to a design-related recall
5. Description of the Device [21 CFR 807.92(a)(4)]
The Spectra Q breast pump is comprised of a Spectra Q pump, breast shield (20, 24, 28, 32 mm), backflow protector, silicone valve, tubing, bottles (including the nipple, cap, cover, and disk), 2-wav connector (for double pumping), and power adapters. The breast pump is provided with one 24 mm and one 28 mm breast shield. Optional components include a small cap converter, assembled with the feeding bottle, the 20 and 32 mm breast shields, and a wide bottle stand.
The Spectra Q breast pump is used by lactating women to express and collect milk from their breasts. The pump is intended for home use by a single user. Pumping with the Spectra Q breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping).
The Spectra O breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -50 to -270 mmHq with cycle rates up to 110 cycles per minute. The device is powered by a 6 V AC/DC power adapter or a 5 V USB C type power adapter. Device specification are listed in Section 7 below. The device is provided non-sterile.
The Spectra Q provides the following user features:
- Five LED indicators for vacuum levels .
- Four buttons for adjustment of on/off, selection of mode, decrease vacuum, and increase ● vacuum
- Massage Mode: pumping pattern with lower vacuum levels and higher cvcle speeds. The ● indicator lights are flickering when operating in massage mode.
- Expression Mode: pumping pattern with higher vacuum levels and lower cycle speeds. The indicator lights are solid when operating in expression mode.
- Option of either single or double (dual) breast pumping
6. Indications for use [21 CFR 807.92(a)(5)]
The Spectra Q is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Q is intended for home use by a single user.
7. Substantial Equivalence Discussion [21 CFR 807.92(a)(6)]
The table below presents comparisons between the subject device (Spectra Q) and the legally marketed predicate device (K162415):
5
| | Spectra Q Breast Pump
(Subject Device)
K191109 | Spectra 9Plus Breast Pump
(Predicate Device)
K162415 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Spectra Q is a powered breast
pump to be used by lactating women
to express and collect milk
from their breasts. The Spectra Q is
intended for home use by a single
user. | The Spectra 9Plus is a single user,
powered breast pump intended to
express and collect milk from the
breasts of lactating women. |
| Single user device | Yes | Yes |
| Intended use
environment | Home | Home |
| Regulation Number | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Product Code | HGX | HGX |
| Device Class | II | II |
| Sterility | Not sterile | Not sterile |
| User Interface and Controls | | |
| User Controls | LED display, buttons for on/off, mode
selection, increase/decrease vacuum | LCD Display, buttons for on/off,
massage mode, increase/decrease
vacuum |
| Pump Options | Single or Double | Single or Double |
| Accessories | • Wide breast shield (size 20/24/28/32
mm)
• Backflow protector
• Silicone valve
• Tubing
• 2-way connector
• 6V AC/CD wall adapter
• 5V USB C power adapter
• Bottle Set (bottle, nipple, cap, disk,
cover) | • Breast Shield
• Backflow protector
• Valve
• Tubing
• 9 V AC/DC wall adapter
• Bottle
• Bottle cover
• Bottle cap |
| Cleaning Method | Breast shield, valve, backflow
protector, and bottle set - wash and
sanitize daily
Tubing – wash and dry if condensation
is present in the tubing | Breast shield, valve, backflow
protector, and bottle set - wash and
sanitize
Tubing – wash and dry if condensation
is present in the tubing
Breast pump body: wipe with damp
cloth |
| Specifications | | |
| Power sources | AC/DC wall adapter (6 V DC)
USB C adapter (5 V DC) | AC/DC Converter (9 V DC)
Rechargeable Lithium-ion battery |
| Pump type | Diaphragm | |
| Suction strength
(massage) | 50 - 150 mmHg | 50 - 150 mmHg |
| Cycles per minute
(massage) | 65 - 110 | 70 |
| Suction levels
(massage) | 5 | 5 |
| Suction strength
(expression) | 130 – 270 mmHg | 50 – 270 mmHg |
| Cycles per minute
(expression) | 25 – 52 | 26 - 60 |
| Suction levels
(expression) | 5 | 10 |
| Backflow Protection | Yes – connector with silicone
membrane to protect against backflow. | Yes – connector with silicone
membrane to protect against backflow. |
Table 1. Comparison of Spectra Q to Predicate Device
6
The subject and predicate devices have similar indications for use and the same intended use expressing milk from the breasts of lactating women. The subject and predicate devices have different technological features. The subiect and predicate device have different user interfaces, cycle ranges, suction strength (expression mode), suction levels (expression mode), and power sources. The differences between the subject and predicate devices do not raise different questions of safety or effectiveness.
Summary of Non-Clinical Tests
The Spectra Q complies with voluntary standards for electrical safety, electromagnetic compatibility, and use in the home healthcare environment. The following non-clinical performance data were provided in support of the substantial equivalence determination:
Electrical Safety/Electromagnetic Compatibility
Testing in accordance with the following standards:
- AAMI / ANSI ES60601-1:2005/A1:2012, Medical Electrical Equipment: Part 1: General . Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2:2014, Medical Electrical Equipment Part 1-2: General Requirements for Basic . Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances -Requirements and Tests
- IEC 60601-1-11:2015, 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 Environment2) Software Validation
Software Validation
Software/firmware verification and validation were provided in accordance with the FDA Guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Biocompatibility
Biocompatibility evaluation was completed according to the FDA quidance "Use of International Standard ISO- 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," dated June 16, 2016, and concluded that no new testing was required, as all patient-contacting materials are identical to those used in the predicate device (K162415). Milk-contacting components were identified and were compliant with appropriate food-contacting regulations (21 CFR 177.1520).
7
Bench Performance Testing
Bench performance testing was conducted with internal test protocols to confirm the minimum and maximum vacuum levels of the pump, as well as cycle rate, meets the listed specifications. The specifications were met for all vacuum levels and cycle rates, for single and double pumping with both power sources (AC/DC wall adapter and USB C adapter). Pump use life testing was conducted to demonstrate the device maintains its specifications throughout its use life under all power sources and worst-case cycle parameters.
8. Conclusion [21 CFR 807.92(b)(3)]
The subject and predicate devices have the same intended use and the technological differences do not raise different questions of safety or effectiveness. The performance data demonstrate the subject device is substantially equivalent to the predicate device.