(198 days)
Not Found
No
The description focuses on mechanical and electrical components, user-controlled settings, and standard medical device testing. There is no mention of AI, ML, or data processing that would indicate such technology.
No
The device is a breast pump, which is intended to express and collect milk. While it may provide comfort or convenience, it is not described as treating or preventing any disease or condition, which would typically characterize a therapeutic device.
No
Explanation: The device is a breast pump, intended to express and collect milk. It does not perform any diagnosis of a medical condition.
No
The device description explicitly details physical components (pump, adaptor, battery, materials like polypropylene, ABS, silicone) and mentions electrical safety and biocompatibility testing, indicating it is a hardware device with embedded 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, or tissue) to detect diseases, conditions, or infections.
- Spectra 9Plus Function: The Spectra 9Plus is a breast pump. Its purpose is to physically express and collect milk from a lactating woman's breasts. It does not perform any diagnostic tests on biological samples.
The provided information clearly describes the device's function as a mechanical aid for milk expression, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Spectra 9Plus is a single user, powered breast pump intended to express and collect milk from the breasts of lactating women.
Product codes
HGX
Device Description
The Spectra 9Plus is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended to be a single patient reusable device. The device is capable of single and dual pumping.
The Spectra 9Plus is powered by a 9V DC adaptor or rechargeable Lithium ion battery. It is composed of materials commonly found in medical devices such as polypropylene, ABS, and silicone. All milk-contacting components are constructed out of food-grade materials that are compliant with 21 C.F.R. parts 174-179.
The Spectra 9Plus is considered a skin-contacting device with a limited (≤24 hours) contact duration.
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, while expression mode has 10 suction levels and 10 cycling speeds. The Spectra 9Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute.
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
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)
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971:2007.
- Electrical Safety Testing in accordance with IEC 60601-1:2005 (3rd 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 1S0-10993, including cytotoxicity (ISO 10993-5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
- Software Validation - Software Life Cycle Processes in accordance with 1EC 62304.
- FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
- Bench Testing - Vacuum Profile Test, Backflow protection test, and Pump use-life test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged to suggest a sense of movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2017
Uzinmedicare Company % Jeffrey Shapiro Director Hyman, Phelps & McNamara, P.C. 700 Thirteenth Street, N.W., Suite 1200 Washington, DC 20005
Re: K162415 Trade/Device Name: Spectra 9Plus Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: Class II Product Code: HGX Dated: February 15, 2017 Received: February 15, 2017
Dear Jeffrey Shapiro:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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,
Benjamin R. Fisher -S
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) K162415
Device Name Spectra 9Plus
Indications for Use (Describe)
The Spectra 9Plus is a single user, powered breast pump 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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510(k) SUMMARY K162415 Spectra 9plus
In accordance with the requirements of 21 C.F.R. § 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 2180 SW 71st Terrace Davie, FL 33317 Telephone: 954-471-4429 Email: hprn@aol.com
DATE SUMMARY PREPARED: March 14, 2017
DEVICE INFORMATION:
Trade Name(s): Common Name: Classification Name: Regulation: Product Code: Class:
Spectra 9Plus Breast pump Powered breast pump 21 C.F.R. § 884.5160 HGX (pump, breast, powered) II
PREDICATE DEVICE INFORMATION:
Double Electric Breast Pump (K092783)
The predicate device has not been subject to a design related recall.
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DEVICE DESCRIPTION:
The Spectra 9Plus is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended to be a single patient reusable device. The device is capable of single and dual pumping.
The Spectra 9Plus is powered by a 9V DC adaptor or rechargeable Lithium ion battery. It is composed of materials commonly found in medical devices such as polypropylene, ABS, and silicone. All milk-contacting components are constructed out of food-grade materials that are compliant with 21 C.F.R. parts 174-179.
The Spectra 9Plus is considered a skin-contacting device with a limited (≤24 hours) contact duration.
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, while expression mode has 10 suction levels and 10 cycling speeds. The Spectra 9Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute.
INTENDED USE:
The Spectra 9Plus is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.
The intended use is similar to that of the predicate device.
COMPARISON TO PREDICATE DEVICE:
The Spectra 9Plus pump system has the same intended use and similar technological characteristics as the Double Electric Breast Pump (K092783). The general device characteristics and key specifications of the Spectra 9Plus pump system and the predicate devices are summarized in the following table:
Comparison of Technological Characteristics
| Attribute | Subject Device
Spectra 9Plus | Predicate Device
Double Electric Breast Pump |
|----------------------|---------------------------------|-------------------------------------------------|
| 510(k) number | K162415 | K092783 |
| Single User | Yes | Yes |
| Provided Non-Sterile | Yes | Yes |
| Re-usable | Yes | Yes |
| Direct User Contact | Yes | Yes |
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| Power Source | AC adapter | |
|---|---|---|
| AC/DC wall converter and | ||
| Rechargeable Lithium-Ion battery | 6 AA alkaline battery | |
| Suction Strength | ||
| (Expression Mode) | ||
| (mmHg) | 50-270 | 50-250 |
| Suction Strength | ||
| (Massage Mode) | ||
| (mmHg) | 50-150 | 50-150 |
| Adjustable Suction | ||
| Levels | Yes | Yes |
| Suction Settings | ||
| (Expression Mode) | 10 | 8 |
| Suction Settings | ||
| (Massage Mode) | 5 | 8 |
| Cycle Speed | ||
| (Expression Mode) | ||
| (cycles/min) | 26-60 | 30-60 |
| Cycle Speed | ||
| (Massage Mode) | 70 | 111 |
| Back Flow Protection | Yes | Yes |
| Single or Double | ||
| Pumping | Single or Double | Single or Double |
| Visual Indicator | LCD | LCD with LED backlight |
| Pump type | Diaphragm | Diaphragm |
The differences between the subject device and the predicate device are as follows:
- There are ten (10) vacuum levels for expression mode and five (5) for massage mode in . Spectra 9Plus, and eight (8) vacuum levels for both expression and massage mode in the predicate device.
- The cycle speed for Spectra 9plus is 26-60 cycles/ min (expression mode) and 70 cycles/ ● min (massage mode), and the cycle speed for predicate device is 30-60 cycles/min (expression mode) and 111 cycles/min (massage mode).
- Spectra 9Plus operates via a Li Ion battery and AC/DC wall adapter and the predicate consists of 6 AA alkaline battery and AC adaptor.
- Spectra 9Plus consist of LCD whereas the predicate device consists of LCD with LED backlight.
The differences between the subject device and predicate device do not raise different questions of safety or effectiveness.
SUMMARY OF NON-CLINICAL TESTS:
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The Spectra 9Plus breast pump complies with voluntary standards for electrical safety. electromagnetic compatibility, use in the home healthcare environment and powered suction pumps.
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971:2007.
- Electrical Safety Testing in accordance with IEC 60601-1:2005 (3rd 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 1S0-10993, including cytotoxicity (ISO 10993-
- 5:2009), sensitization (ISO 10993-10:2010) and irritation (ISO 10993-10:2010).
- . Software Validation - Software Life Cycle Processes in accordance with 1EC 62304.
- . FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
- Bench Testing - Vacuum Profile Test, Backflow protection test, and Pump use-life test.
CONCLUSION:
The Spectra 9Plus breast pump is substantially equivalent to the legally marketed predicate device, Double Electric Breast Pump.