(312 days)
Not Found
No
The description details a mechanical breast pump with an AC motor and piston pump, and there is no mention of AI, ML, or related concepts in the provided text.
No
The primary function of a breast pump is to extract breast milk, which is a physical process rather than a therapeutic intervention to treat a disease, injury, or impairment. While it supports breastfeeding, which has health benefits, the device itself is not therapeutic.
No
The device description states its purpose is to express breast milk, which is a functional task, not a diagnostic one. It does not mention analyzing any biological parameters to determine a medical condition.
No
The device description explicitly states it is operated by an AC motor and drives a piston pump, indicating it is a hardware device with mechanical components, not software-only.
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 breast milk from the breast of lactating woman." 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 creates a vacuum to extract milk. This aligns with a physical device, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or the breast milk itself for diagnostic purposes), reagents, or any process related to diagnosing a disease or condition.
- Anatomical Site: The anatomical site is the breast, which is where the physical action of expressing milk occurs.
- Intended User: The intended user is a "lactating woman," who is using the device for a physical function.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This breast pump does not fit that description.
N/A
Intended Use / Indications for Use
The Spectra electric breast pump is intended to express breast milk from the breast of lactating woman.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Spectra Series Breast Pump is operated by AC motor, The device's motor drives a Piston pump, creating a vacuum to express breast milk. Passing through an air tubing to breast shield, the vacuum is used to comfortably draw out the breast milk. This device operates with power ON at the same time. Also, vacuum regulate operates, and I adjust a vacuum. ON, OFF of a device means opening of absorption and end. Regular this which is international or foods of FDA shall obey it to safe sanitary rules etc. related to contacts of mother's milk that I faced it to things come in contact on matter or human chest etc.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
All testing of this subject device has demonstrated that the Spectra Series breast pump meets established requirements when used in the manner and environment specified in product labeling.
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
K093145 page 1 of 3
510(k) SUMMARY of Safety and Effectiveness
The following 510(k) summary is being submitted as required by 21 CFR 807.92(a):
AUG 1 3 2010
1.Submitter's Information
UZINMEDICARE CO.
503-2, Chang-Ri, Namsa-Myeon, Yongin, Kyeonggi-Do, Korea, Zip:449-885 Phone : +82-31-322-0132
2. Contact Name
Yong J. Choi Name:
Title : Manager
Address: 503-2, Chang-Ri, Namsa-Myeon, Yongin, Kyeonggi-Do, Korea,
Zip 449-885
Phone No.: +82-10- 5069-7155
Fax No .: +82- 31- 322- 4292
E-Mail: choiyyjj@yahoo.com
Contact person in U.S.
Name: DANIEL MIN
Address: 904-274th Way SESAMMAMISH, WA 98075, USA
Phone No .: 1- 206-510-8006
Fax No.: 1-428-369-8795
E-Mail: wwjdksn@hotmail.com
3. Device Identification
Proprietary Name: Spectra Series Breast Pump Common/Usual Name: Powered Breast Pump Classification Name: Powered Breast Pump per 21 CFR § 884.5160 Product Code: HGX
1
Image /page/1/Picture/1 description: The image shows a logo for "spectra". The logo is in black and white and features the word "spectra" in a stylized font. The "C" in "spectra" is larger than the other letters. The word is inside of a rounded shape, and there is a horizontal line underneath the shape.
Kogzil 4
age Zof3
4.Classification of Device
FDA has classified the predicate devices(K061013, K950750, K973501) as class II, CFR § 884.5160. It is our understanding that the powered breast pump fall under the same classification, Sec. § 884.5160 as the predicate devices.
5.Reason for 510(k) Submission
Initial Product Introduction is the reason for submitting the 510(k).
6. Identification of legally marketed predicate device
The subject device is deemed to be substantially equivalent to those following devices manufactured and currently available in commercial distribution.
| | Uzinmedicare
Spectra Series | Playtex
Embrace Petite
Breast Pump | Medela Lactina
Plus | Ameda Purely
Yours |
|--------------------------------------|--------------------------------|------------------------------------------|------------------------|-----------------------------------------|
| 510(k) Number | N/A | K061013 | K950750 | K973501 |
| Intended Use | To Express Milk | To Express Milk | To Express Milk | To Express Milk |
| Power Source | AC Power Supply | DC Power
Supply | AC Power
Supply | DC Power
Supply or 6 AA
Batteries |
| Pump Type | Piston | Piston | Piston | Piston |
| Single or Double
Pumping | Both | Both | Both | Both |
| Adjustable Suction
Levels | Yes | Yes | Yes | Yes |
| Adjustable Cycle
Speed | No | No | No | Yes |
| Overflow Protection | Yes | Yes | No | Yes |
| Highest Vacuum
Setting(mmHg) | 400 Less than | 214 | 240 | 163 |
| Lowest Vacuum
Setting(mmHg) | 150 | 72 | 100 | 21 |
| Range of Cycle
Speeds(Cycles/min) | 46-47 | 45 | 66-41 | 67-29 |
| Weight (Kg) | 2.1 | - | 2.4 | - |
2
Image /page/2/Picture/3 description: The image shows the word "spectra" in a stylized font. The "C" in "spectra" is capitalized and larger than the other letters. The word is inside of a black oval shape with a white outline. There is a black line underneath the oval shape.
7. Description of Device
The Spectra Series Breast Pump is operated by AC motor, The device's motor drives a Piston pump, creating a vacuum to express breast milk. Passing through an air tubing to breast shield, the vacuum is used to comfortably draw out the breast milk.
This device operates with power ON at the same time. Also, vacuum regulate operates, and I adjust a vacuum. ON, OFF of a device means opening of absorption and end.
Regular this which is international or foods of FDA shall obey it to safe sanitary rules etc. related to contacts of mother's milk that I faced it to things come in contact on matter or human chest etc.
8. Indications for Use
The Spectra electric breast pump is intended to express breast milk from the breast of lactating woman.
9. Discussion of Non Clinical Tests
All testing of this subject device has demonstrated that the Spectra Series breast pump meets established requirements when used in the manner and environment specified in product labeling.
10.Conclusion
The Spectra Series Breast Pump has the same intended use and similar technological characteristics as the predicate devices. Thus, we are claiming that the Spectra Series Breast Pump is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002.
Yong J. Choi Manager Uzinmedicare Co. 503-2, Chang-Ri, Namsa-Myeon Yongin-Si, Kyeonggi-Do 449-885, KOREA
Re: K093145
Trade Name: Spectra Series Breast Pump
Regulation Number: 21 CFR 8884.5160 . Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: May 20, 2010 Received: May 21, 2010
Dear Mr. Choi:
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. 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
AUG 1 3 2010
4
Page 2
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/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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Hubert Lenoir MD
erbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
5
Uzinmedicare Co.
503-2,Chang-Ri, Namsa-Myeon, Yongin-Si, Kyeonggi-Do 449-885, Korea Tel.82-31-322-0132/Fax.82-31-322-4292
Image /page/5/Picture/2 description: The image shows a handwritten text string. The string appears to be a code or identifier, consisting of a combination of letters and numbers. The text reads 'K09 3/45', with a slightly slanted orientation. The handwriting is clear and legible, with distinct strokes forming each character.
Image /page/5/Picture/3 description: The image shows the logo for Spectra. The logo is in a black oval shape with the word "spectra" written in white letters inside. The "C" in "spectra" is capitalized. The logo is surrounded by a black border.
Indications for Use
510(k) Number (if known): K093145 AUG 1 3 2010
Creative Studio
Device Name:
Spectra Series Breast Pump
Indications for Use:
The Spectra electric breast pump is Single user product and intended to express breast milk from the breast of lactating woman.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use V (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K093145