(416 days)
No
The description details a standard powered breast pump with user-controlled settings and no mention of AI/ML terms or capabilities.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is a breast pump, which simply expresses and collects milk, and does not treat or prevent any specific medical condition.
No
Explanation: The device is a breast pump designed to express and collect milk, not to diagnose a medical condition.
No
The device description clearly describes a physical, powered breast pump with hardware components (buttons, motor, battery, adaptor) and does not indicate it is solely software.
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, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a mechanical pump that creates vacuum and cycles to extract milk. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly a medical device, but its function is therapeutic/supportive (milk expression) rather than diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
HGX
Device Description
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. 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 S1 Plus and Spectra S2 Plus are capable of providing vacuum levels from 50-280 mmHg with cycling rates up to 70 cycles per minute. The Spectra S1 Plus is powered by a 12V DC adaptor or rechargeable lithium battery. The Spectra S2 Plus is powered only by a 12V DC adaptor.
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
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
Non-clinical testing was conducted including:
- Risk Analysis developed in accordance with ISO 14971:2007.
- Electrical Safety Testing in accordance with IEC 60601-1:2005 (3m Edition) with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2007.
- Safety Testing for use in the home in accordance with IEC 60601-1-11:2010.
- Biocompatibility Tests in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
- Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
- Medical Device Software - Software Life Cycle Processes in accordance with IEC 62304.
Performance testing was conducted at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. Tests were conducted for 20 minutes to simulate a typical pumping session. The specifications were met for vacuum level, cycle rate, backflow protection and battery operation time. These results held under conditions of single and double pumping mode and for the Spectra S1 Plus model, of varying power sources (e.g., AC/DC power vs. battery power).
Clinical testing was not required to demonstrate the substantial equivalence of the Spectra S1 Plus and Spectra S2 Plus breast pumps to its predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest feathers or wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2016
Uzinmedicare Co. % Ho Dong Yang CEO Onbix Corporation #821 Samil Plaza, 837-26 Yeuksam-dong Gangnam-gu, Seoul 135-768 Republic of Korea
Re: K150476 Trade/Device Name: Spectra S1 Plus and Spectra S2 Plus Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: Class II Product Code: HGX Dated: March 9, 2016 Received: March 9, 2016
Dear Ho Dong Yang,
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Herbert P. Lerner -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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | |
|---|---|
| Indications for Use | Form Approved: OMB No. 0910-0120 |
| Expiration Date: January 31, 2017 | |
| See PRA Statement below. | |
| 510(k) Number (if known) | K150476 |
| Device Name | Spectra S1 Plus and Spectra S2 Plus |
| Indications for Use (Describe) | 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. |
| Type of Use (Select one or both, as applicable) | |
| Prescription Use (Part 21 CFR 801 Subpart D) 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."
| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| ---------------------- | ------------- |
PSC Publishing Services (301) 443-6740 EF
.
में
3
510(k) SUMMARY
K150476
In accordance with the requirements of 21 CFR §807.92, the following summary is provided:
SUBMITTER INFORMATION:
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 2181 Court, Suite 1 Davie, FL 33317 Telephone: 954-471-4429 E-mail: hprn@aol.com
DATE SUMMARY PREPARED:
March 21, 2016
DEVICE INFORMATION:
Trade Name(s): Classification Name: Powered breast pump Regulation: Product Code:
Spectra S1 Plus and Spectra S2 Plus 884.5160 HGX
PREDICATE DEVICE INFORMATION:
PJ's Comfort® Trade Name(s): Classification Name: Powered breast pump Regulation: 884.5160 Product Code: HGX
4
DEVICE DESCRIPTION:
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. 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 S1 Plus and Spectra S2 Plus are capable of providing vacuum levels from 50-280 mmHg with cycling rates up to 70 cycles per minute. The Spectra S1 Plus is powered by a 12V DC adaptor or rechargeable lithium battery. The Spectra S2 Plus is powered only by a 12V DC adaptor.
INDICATIONS FOR USE STATEMENT:
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.
COMPARISON TO PREDICATE DEVICE:
The Spectra S1 Plus and Spectra S2 Plus breast pumps have intended use and the same technological characteristics as the Limerick PJ Comfort® (K051926).The general device characteristics and key specifications of the Spectra S2 Plus breast pumps and its predicate device are summarized in the following table:
| Subject Device (K150476) | Predicate Device (K051926) | |
|---|---|---|
| GENERAL DEVICE CHARACTERISTICS | ||
| Product Name | Spectra S1 Plus and Spectra S2 Plus | PJ's Comfort |
| Manufacturer | Uzinmedicare Co. | Limerick, Inc. |
| Product Code | HGX | HGX |
| Regulation No. | 21 CFR 884.5160 | 21 CFR 884.5160 |
| Class | Class II | Class II |
| Patient Population | Breastfeeding women | Breastfeeding women |
| Indications for Use | The Spectra S1 Plus and Spectra S2 Plus are | |
| single-user, powered breast pumps intended to | The PJ's Comfort breast pump is an electrically | |
| powered (diaphragm type) suction device intended | ||
| express and collect milk from the breasts of | ||
| lactating women. | to express and collect milk from the breasts of | |
| lactating women. | ||
| SPECIFICATIONS | ||
| Pump Type | Diaphragm | Diaphragm |
| Pump Options | Single or Double | Single or Double |
| Suction Levels | Massage Mode: 5 levels | |
| Expression Mode: 12 Levels | Unknown | |
| Suction Strength | 50-280 mmHg | 40-270 mmHg |
| Cycle Speed | 38-70 cycles/min (adjustable) | 16-70 cycles/min (adjustable) |
| Visual Indicator | LCD | Markings and illuminated lights on panel |
| Power Supply | ||
| (Conventional Outlet) | AC/DC wall converter | AC/DC wall converter |
| Power Supply | ||
| (Battery) | Rechargeable Lithium Ion Battery | |
| (only for Spectra S1 Plus) | Rechargeable NiMH Battery | |
| Power Supply | ||
| (Car Adapter) | N/A | 12 V |
5
| Back Flow Protection
1 UD
| ﻟﻠﻘﺎﻧﻮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ |
|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
SUMMARY OF NON-CLINICAL TESTS:
The Spectra S1 Plus and Spectra S2 Plus breast pumps comply with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and powered suction pumps. The following data were provided to support the substantial equivalence determination:
- Risk Analysis developed in accordance with ISO 14971:2007.
- . Electrical Safety Testing in accordance with IEC 60601-1:2005 (3m Edition) with US deviations per AAMI/ANSI ES 60601-1:2005/(R)2012 and A1:2012.
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2007.
- Safety Testing for use in the home in accordance with IEC 60601-1-11:2010.
- . Biocompatibility Tests in accordance with ISO-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
- . Software verification and validation testing as recommended in FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
- Medical Device Software - Software Life Cycle Processes in accordance with IEC 62304.
Performance testing was conducted at minimum and maximum vacuum settings to determine the minimum and maximum vacuum levels of the pump as compared to its specifications. Tests were conducted for 20 minutes to simulate a typical pumping session. The specifications were met for vacuum level, cycle rate, backflow protection and battery operation time. These results held under conditions of single and double pumping mode and for the Spectra S1 Plus model, of varying power sources (e.g., AC/DC power vs. battery power).
SUMMARY OF CLINICAL TESTS:
Clinical testing was not required to demonstrate the substantial equivalence of the Spectra S1 Plus and Spectra S2 Plus breast pumps to its predicate device.
CONCLUSION:
The differences between the Spectra S1 Plus and Spectra S2 Plus breast pumps and its predicate device do not introduce a new intended use and do not raise of safety and effectiveness. Based on non-clinical testing. Uzinmedicare Co. concludes that the Spectra S1 Plus and Spectra S2 Plus breast pumps perform as intended and are substantially equivalent to the legally marketed predicate device, Limerick's PJ Comfort.