(150 days)
K150476 Spectra S1 Plus Breast Pump
Not Found
No
The device description details manual control of vacuum and cycle levels via buttons, and the performance studies focus on basic functional tests like vacuum, battery usage, and cycle rate. There is no mention of AI or ML in the description, intended use, or performance testing.
No.
The device is a breast pump used by lactating women to express and collect milk, which is a supportive rather than therapeutic function.
No
The device is a breast pump, used to express and collect milk, which is a therapeutic or supportive function, not a diagnostic one.
No
The device description clearly outlines a physical breast pump with hardware components such as buttons, a motor, a power source (AC adaptor or battery), and the ability to generate vacuum and control cycle rates. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Spectra 3 Plus Function: The Spectra 3 Plus Breast Pump is a mechanical device used to physically express and collect breast milk. It does not perform any tests on biological samples to diagnose or monitor a medical condition.
The description clearly states its purpose is to "express and collect milk from their breast," which is a physical process, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Spectra S3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra S3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Spectra S3 Plus is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to switch from massage mode to expression mode, and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed option, while expression mode has 12 suction levels and 5 cycle speed levels. The Spectra S3 Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute. The Spectra S3 Plus is powered by a 12V DC adaptor or rechargeable lithium battery.
The Spectra S3 Plus breast pump can be used by multiple users. Kits used with the Spectra S3 Plus breast pump, however, are labeled for a single user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast
Indicated Patient Age Range
Lactating women
Intended User / Care Setting
Home use by a single user, or multiple users in a hospital setting.
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)
As stated previously, the only substantive difference between the subject and predicate device is that the subject device is a multi-user pump. Therefore, the subject device leverages performance data conducted on the predicate device. The following new performance tests were conducted on the subject device:
- Vacuum test (battery and AC) to demonstrate that the pump vacuum meets . specifications during single pumping and double pumping with battery or AC power (110 VAC, 60 Hz),
- Battery usage test to demonstrate battery usage time, ●
- Cycle test to demonstrate that the pump cycle rate meets specifications while ● running on battery or AC power,
- Breast shield size test to demonstrate that the pump meets vacuum specifications . with all breast shield sizes,
- Backflow protection test to demonstrate that milk cannot flow through the ● backflow protector into the breast pump.
The performance data demonstrates that the Spectra S3 Plus breast pump 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.
K150476 Spectra S1 Plus Breast Pump
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.
November 30, 2018
Uzinmedicare Co. % Adrienne R. Lenz Senior Medical Device Regulation Expert Hyman, Phelps, & McNamara, P.C. 700 Thirteenth N.W., Suite 1200 Washington, D. C. 20005
Re: K181784
Trade/Device Name: Spectra S3 Plus Breast Pump Regulation Number: 21 CFR& 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: October 30, 2018 Received: October 31, 2018
Dear Adrienne R. Lenz:
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 statutes and regulations administered by other Federal agencies.
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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.html; 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 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
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Indications for Use
510(k) Number (if known) K181784
Device Name Spectra S3 Plus Breast Pump
Indications for Use (Describe)
The Spectra 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also 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)
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510(k) Summary - K181784
In accordance with 21 C.F.R. § 807.92 the following summary of information is provided:
DATE PREPARED: November 30, 2018
SUBMITTER:
UZINMEDICARE CO
Room 105, Joongang Induspia V, Sagimakgolo 137, Jungwon-gu, Seoungnam-Si, Gyeonggi-do, 13202, South Korea
PRIMARY CONTACT PERSON:
Nathan Ahn, Manager Overseas Department c/o UZINMEDICARE CO Room 105, Joongang Induspia V, Sagimakgolo 137, Jungwon-gu, Seoungnam-Si, Gyeonggi-do, 13202, South Korea Telephone: 82-31-739-5271 Email: shahn@uzinmedical.co.kr
SECONDARY CONTACT PERSON:
Heidi Humphries, RN, BSN, IBCLC Spectra Baby USA 6851 SW 21ST Court, Suite 1 Davie, FL 33317 Telephone: 954-471-4429 E-mail: hprn@aol.com
DEVICE:
TRADE NAME: Spectra S3 Plus Breast Pump COMMON/USUAL NAME: Breast Pump REGULATION NAME: Powered Breast Pump REGULATION NUMBER: 21 CFR 884.5160
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REVIEW PANEL: Obstetrics/Gynecology PRODUCT CODE: HGX (pump, breast, powered) REGULATORY CLASS: II
PREDICATE DEVICE(S):
K150476 Spectra S1 Plus Breast Pump The predicate device has not been subject to a design related recall.
DEVICE DESCRIPTION:
The Spectra S3 Plus is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to switch from massage mode to expression mode, and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed option, while expression mode has 12 suction levels and 5 cycle speed levels. The Spectra S3 Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute. The Spectra S3 Plus is powered by a 12V DC adaptor or rechargeable lithium battery.
The Spectra S3 Plus breast pump can be used by multiple users. Kits used with the Spectra S3 Plus breast pump, however, are labeled for a single user.
INDICATIONS FOR USE:
The Spectra S3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra S3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
PREDICATE DEVICE COMPARISION:
As summarized in the table below, the subject and predicate device have the same intended use - express and collect breast milk. Regarding technological characteristics, the only substantive difference between the subject and predicate device is that the subject device pump is for use by multiple users while the predicate device is for use by a single user. This difference in technological characteristics does not raise different questions of safety or effectiveness.
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| | Spectra S1 Plus Breast Pump
Predicate Device (K150476) | Spectra S3 Plus Breast Pump |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient
Population | Breastfeeding women | Breastfeeding women |
| Indications
for Use | The Spectra S1 Plus is a single-
user powered breast pump
intended to express and collect
milk from the breasts of lactating
women. | The Spectra S3 Plus Breast Pump
is a powered breast pump to be
used by lactating women to
express and collect milk from their
breast. The Spectra S3 Plus Breast
Pump is intended for multiple
users in a hospital setting. It is
also intended for home use by a
single user. |
| Use Type | Single user | Multi-user and single user |
| Environment
of Use | Home | Hospital, Home |
| User Interface | LCD display, buttons, night light | LCD display, buttons, night light |
| Modes of
Operation | Massage, Expression | Massage, Expression |
| Single/Double
Pumping | Single or Double | Single or Double |
| Accessories | Breast shield set, includes
flange (28 mm) backflow protector valve tubing 12V AC Power adapter
Bottle Set (bottle, nipple, cap,
disk, cover) | Breast shield set, includes
flange (size 20, 24, 28 and 32 mm) backflow protector valve tubing 12V AC Power adapter
Bottle Set (bottle, nipple, cap,
disk, cover) |
| Pump Type | Diaphragm | Diaphragm |
| Suction
Levels | 12 Levels | 12 Levels |
| Suction
Strength | $50 (\pm 50) $ mmHg to 270 (-50
mmHg) (maximum 270 mmHg) | $50 (\pm 50) $ mmHg to 270 (-50
mmHg) (maximum 270 mmHg) |
| | Spectra S1 Plus Breast Pump
Predicate Device (K150476) | Spectra S3 Plus Breast Pump |
| Cycle Speed | 38-70 cycles/min (adjustable) | 38-70 cycles/min (adjustable) |
| Power Supply
(Conventional
Outlet) | AC/DC wall converter
Input 100V – 240AC, 50/60Hz,
600mA
Output: 12V, 2A | AC/DC wall converter
Input 100V – 240AC, 50/60Hz,
600mA
Output: 12V, 2A |
| Power Supply
(Battery) | Rechargeable Lithium Ion Battery
11.1V 2000mAh Li-Polymer | Rechargeable Lithium Ion Battery
11.1V 2000mAh Li-Polymer |
| Back Flow
Protection | Yes, provided by silicone
membrane backflow protector | Yes, provided by silicone
membrane backflow protector |
| Software | Yes | Yes |
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SUMMARY OF PERFORMANCE DATA:
SUMMARY OF NON-CLINICAL TESTS:
As stated previously, the only substantive difference between the subject and predicate device is that the subject device is a multi-user pump. Therefore, the subject device leverages performance data conducted on the predicate device. The following new performance tests were conducted on the subject device:
- Vacuum test (battery and AC) to demonstrate that the pump vacuum meets . specifications during single pumping and double pumping with battery or AC power (110 VAC, 60 Hz),
- Battery usage test to demonstrate battery usage time, ●
- Cycle test to demonstrate that the pump cycle rate meets specifications while ● running on battery or AC power,
- Breast shield size test to demonstrate that the pump meets vacuum specifications . with all breast shield sizes,
- Backflow protection test to demonstrate that milk cannot flow through the ● backflow protector into the breast pump.
In addition, the labeling was updated to reflect use by multiple users and to include
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corresponding warnings, precautions, and cleaning instructions.
CONCLUSION:
The performance data demonstrates that the Spectra S3 Plus breast pump is substantially equivalent to the predicate device.