(36 days)
ISIS iQ UNO Handheld Electronic Breast Pump
No
The description mentions "electronic memory" and "pre-programmed settings," which are standard features for electronic devices and do not indicate the use of AI or ML. There is no mention of learning, adaptation, or complex algorithms that would typically characterize AI/ML.
No
Therapeutic devices are generally used to treat or cure a disease or condition. This device is a breast pump used to express and collect milk, which is not a therapeutic function.
No
The device is a breast pump, which is used to express and collect milk. Its purpose is not to diagnose any medical condition or disease.
No
The device description clearly outlines physical components like a breast pump, funnel, and electronic memory, indicating it is a hardware device with some electronic control, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is designed to express and collect milk from the breasts of lactating women. This is a mechanical process involving the body directly, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states its purpose is to collect milk, not to diagnose or test for any condition.
- Device Description: The description focuses on the mechanical and electronic features of the pump, not on any analytical or diagnostic capabilities.
- Performance Studies: The performance studies evaluate the pump's mechanical performance (suction, speed, flow rate) and durability, not the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is indicated to express and collect milk from the breasts of lactating women.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is a BPA-free breast pump designed with an electronic memory that allows the lactating mother to save and control personal pump settings or use one of the two settings that are already pre-programmed. The "soft flex" funnel protects and actuates in and out, replicating baby's suckling action and stimulating a fast, natural let-down. In addition to mains power, this single electronic pump can also operate using battery power or as a manual pump.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
-
. Performance
The components of the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump were evaluated to ensure that the recommended cleaning/sanitization procedures would not significantly alter the material/geometry of the pump components nor negatively impact the overall efficiency/ operation of the pump. In addition, laboratory testing was conducted to estimate the "life cycle" of the device as approximately 1.6 years. Finally, testing was conducted on the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump and the ISIS iQ UNO Handheld Electronic Breast Pump as to evaluate and compare the general performance characteristics (i.e., suction, speeds, and flow rates) of these devices. Based on this study, both devices performed substantially equivalent in terms of suction, speeds, and flow rate (i.e., rate of fluid/milk extraction). -
Biocompatibility
The Softflex™ Funnel (or Flex Horn) is the only patient-contacting component associated with the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump. This component was tested and passed all required biocompatibility testing (i.e., cyctotoxicty, sensitization, and intracutaneous reactivity, and acute systemic toxicity) conducted in accordance with ISO 10993. In addition, the milk-contacting components comply with 21CFR 174 and 177. -
Electrical ●
The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump complies with the medical electrical equipment requirements defined by IEC 60601-1-2 and IEC/UL 60601-1 for electromagnetic compatibility and electrical safety, respectively.
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
K 100385
pg 1 of 2
510(k) Summary (per 21 CFR 807.92(c))
1. Applicant
Luv n' care", Ltd. 3030 Aurora Ave. Monroe, LA 71201
Joseph Hakim, President Tel: (800) 588-6227 Fax: (318) 388-5892 E-mail: josephh@nuby.com
Date Prepared: November 11, 2009
2. Device Name
| Device Name: | Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump |
|---|---|
| Device: | pump, breast, powered |
| Regulation Description: | Powered breast pump. |
| Regulation Number: | 884.5160 |
| Product Code: | HGX |
| Device Class: | II |
| Review Panel: | Obstetrics/Gynecology |
3. Predicate Devices
The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is substantially equivalent to the following device:
| 510(k)
| Number | Device | Applicant |
|---|---|---|
| K052047 | ISIS iQ UNO Handheld Electronic Breast Pump | Avent America, Inc. |
4. Indications for Use
The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is indicated to express and collect milk from the breasts of lactating women.
MAR 2 4 2010
ﺪﻭ ﭘﺮ ﭘﺮﻭ
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Image /page/1/Picture/0 description: The image shows handwritten text. The first line reads "K100385". The second line reads "pg. 2 of 2". The text appears to be a page number or document identifier.
The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is a BPA-free breast pump designed with an electronic memory that allows the lactating mother to save and control personal pump settings or use one of the two settings that are already pre-programmed. The "soft flex" funnel protects and actuates in and out, replicating baby's suckling action and stimulating a fast, natural let-down. In addition to mains power, this single electronic pump can also operate using battery power or as a manual pump.
Summary of the Technical Characteristics 6.
-
. Performance
The components of the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump were evaluated to ensure that the recommended cleaning/sanitization procedures would not significantly alter the material/geometry of the pump components nor negatively impact the overall efficiency/ operation of the pump. In addition, laboratory testing was conducted to estimate the "life cycle" of the device as approximately 1.6 years. Finally, testing was conducted on the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump and the ISIS iQ UNO Handheld Electronic Breast Pump as to evaluate and compare the general performance characteristics (i.e., suction, speeds, and flow rates) of these devices. Based on this study, both devices performed substantially equivalent in terms of suction, speeds, and flow rate (i.e., rate of fluid/milk extraction). -
Biocompatibility
The Softflex™ Funnel (or Flex Horn) is the only patient-contacting component associated with the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump. This component was tested and passed all required biocompatibility testing (i.e., cyctotoxicty, sensitization, and intracutaneous reactivity, and acute systemic toxicity) conducted in accordance with ISO 10993. In addition, the milk-contacting components comply with 21CFR 174 and 177. -
Electrical ●
The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump complies with the medical electrical equipment requirements defined by IEC 60601-1-2 and IEC/UL 60601-1 for electromagnetic compatibility and electrical safety, respectively.
7. Safety and Effectiveness
The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is as safe and effective as the predicate device listed in this 510(k) submission. The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump and the ISIS iQ UNO Handheld Electronic Breast Pump (K052047) have the same indications for use and are similar in both design and function. Any differences in technological characteristics between the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump and the predicate device do not raise issues of safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Luv N' Care, Ltd. c/o Casey Conry Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747
MAR 2 4 2010
Re: K100385
Trade/Device Name: Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump Regulation Number: 21 CFR §884.5160 Regulation Name: Powered Breast Pump Regulatory Class: II Product Code: HGX Dated: March 10, 2010 Received: March 11, 2010
Dear Mr. Conry:
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
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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/CDRH/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.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K100385 510(k) Number (if known):
Device Name: Nuby™ Natural Touch Rhythm™ Dual Action Electric Pump Electric Breast Pump
Indications for Use:
The Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump is indicated to express and collect milk from the breasts of lactating women.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
Hent L. Sh
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number 100385