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.

AI/ML Overview

This document is a 510(k) summary for the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump, focusing on its substantial equivalence to a predicate device. It describes performance testing but does not detail a study with specific acceptance criteria that would typically be associated with a clinical trial or a performance study designed to achieve quantitative metrics like sensitivity, specificity, or improvement over a baseline in a medical imaging or diagnostic context.

Therefore, many of the requested sections about acceptance criteria, study details, expert involvement, and statistical analyses (like MRMC studies) are not applicable to this type of regulatory submission. The submission focuses on demonstrating substantial equivalence through component-level testing and general performance comparisons.

Summary of Device Performance and Acceptance Criteria (Based on Provided Document):

The document describes several forms of testing to demonstrate the device's safety and effectiveness, primarily through comparison with a predicate device and compliance with established standards.

Acceptance Criteria Category	Specific Criteria / Test	Reported Device Performance
Material Integrity	Cleaning/sanitization procedures should not significantly alter material/geometry of pump components nor negatively impact efficiency/operation.	Components were evaluated and found to meet this criterion.
Durability / Life Cycle	Device life cycle.	Estimated life cycle of approximately 1.6 years.
General Performance Characteristics (Comparison with Predicate)	Substantial equivalence in suction, speeds, and flow rates compared to the ISIS iQ UNO Handheld Electronic Breast Pump.	Both devices performed substantially equivalently in terms of suction, speeds, and flow rate (i.e., rate of fluid/milk extraction).
Biocompatibility	Softflex™ Funnel (patient-contacting component) must pass biocompatibility testing per ISO 10993 (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity).	The Softflex™ Funnel was tested and passed all required biocompatibility testing.
Food Contact Compliance	Milk-contacting components must comply with 21 CFR 174 and 177.	Milk-contacting components comply with 21CFR 174 and 177.
Electrical Safety	Compliance with IEC/UL 60601-1 for electrical safety.	The device complies with IEC/UL 60601-1.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2 for electromagnetic compatibility.	The device complies with IEC 60601-1-2.

Study Details Provided in the Document:

2. Sample size used for the test set and the data provenance:

Test Set: Not explicitly stated for the "general performance characteristics" comparison. The comparison states "testing was conducted on the Nuby™ Natural Touch Rhythm™ Dual Action Electric Breast Pump and the ISIS iQ UNO Handheld Electronic Breast Pump." This implies a comparative bench test rather than a clinical study with human subjects.
Data Provenance: The document does not specify the country of origin for the data or if it was retrospective or prospective. Given the nature of the testing described (material integrity, life cycle, pump performance), it primarily refers to laboratory testing and bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for this device's performance evaluation is based on engineering specifications, regulatory standards, and objective measurements of physical characteristics (e.g., suction, flow rate) using laboratory equipment, not expert human interpretation.

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where expert human review is required to establish ground truth from subjective data (e.g., image interpretation). This document describes objective engineering and material testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting data. It is a powered breast pump.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm-based device. The performance cited refers to the mechanical and electrical functioning of the breast pump itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance evaluation primarily consists of:
- Objective engineering measurements: for suction, speeds, flow rates, and electrical parameters.
- Standardized laboratory tests: for material integrity, life cycle estimation, and biocompatibility (e.g., ISO 10993 cytotoxicity, sensitization).
- Regulatory compliance standards: for electrical safety (IEC 60601-1, IEC 60601-1-2) and food contact materials (21 CFR 174 and 177).

8. The sample size for the training set:

Not applicable. This device does not use machine learning or AI that would require a "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for an AI/ML algorithm.

Summary

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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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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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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

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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

Regulation Number and Section

§ 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).