This electric breast pump product is designed to provide everything a mother will need to start sterilizing, expressing, storing and feeding. The pump unit has 3 alternate settings: light, medium and high suction levels during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2 oz pot, which fits into "Closer to Nature" bottles for feeding. The product is designed to use, one pot size for expressing, storing and feeding. This device is Mains or Battery powered.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Tommee Tippee Closer to Nature® Electric Breast Pump, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in a formal table; instead, the device performance is measured against a legally marketed predicate device (Medela AG, SwingTM electric breast pump) to demonstrate substantial equivalence. The "acceptance criteria" can therefore be inferred as demonstrating no significant difference or (in one case) a slight improvement compared to the predicate device.

Acceptance Criteria (Inferred from Comparison)	Reported Device Performance (Tommee Tippee Closer to Nature® Electric Breast Pump)	Predicate Device Performance (Medela Swing)	Outcome (vs. Predicate)
Pump vacuum (bare): No significant difference in vacuum capability when removed from housing	-40 kPa	-38 kPa	No significant difference
Pump vacuum (installed): No significant difference in vacuum capability when installed in housing	Up to -38 kPa	Up to -36 kPa	No significant difference
Lowest vacuum capability (installed, simulated use): No significant difference in lowest vacuum during use	-20 kPa	-29 kPa	Draws a slightly lower vacuum (which can be interpreted as improved comfort/gentleness)
Suction rate (liquid flow ability): No significant difference in ability to flow liquid (volume displaced in a given time)	180 mL in 2 minutes	150 mL in 2 minutes	No significant difference
Material Selection: All milk and human contact components to meet appropriate FDA regulations (food contact, biocompatibility)	Meets FDA food additive criteria (21 CFR Parts 176, 177, 178); Skin contacting materials satisfy ISO 10993 for skin contact	(Implied to meet similar standards as a legally marketed device)	No significant difference

Important Note: The document consistently concludes "This shows there is no significant difference in the devices," even when numerical values are different (e.g., 180 mL vs 150 mL or -20 kPa vs -29 kPa). This indicates that the observed differences were considered within acceptable limits for substantial equivalence.

Study Details

Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for the tests conducted. It refers to "A direct comparison of the pumps was carried out," implying a limited, technical comparison rather than a large-scale clinical study with a "test set" of participants in the traditional sense.
- Data provenance: Not explicitly stated, but the nature of the tests (direct measurement of pumps, simulated use) suggests laboratory or engineering testing rather than human clinical data from specific countries. It's likely internal testing conducted by Mayborn Group Limited.
- Retrospective or prospective: Not applicable in the traditional sense for these engineering tests. These were likely prospective tests for the purpose of the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is objective physical measurements (vacuum, fluid displacement, material compliance with regulations) rather than expert interpretation of complex data (e.g., images).
Adjudication method for the test set:
- Not applicable. The "ground truth" is based on direct physical measurements, not subjective expert opinion requiring adjudication.
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:
- No. This is a medical device (breast pump) and not an AI-powered diagnostic imaging device. An MRMC study is not relevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a way. The tests described (measurements of vacuum, fluid displacement, material compliance) are evaluations of the device's inherent performance characteristics, which is analogous to a "standalone" or "algorithm only" performance for an engineering device. There is no human-in-the-loop component in these specific comparative tests.
The type of ground truth used:
- Objective physical measurements: Direct measurements of vacuum pressure (kPa), fluid volume (mL), and time.
- Regulatory compliance: Verification that materials meet specified FDA regulations (21 CFR Parts 176, 177, 178) and ISO biocompatibility standards (ISO 10993).
The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set. The "development" and "testing" phases refer to engineering design and verification, not algorithmic training.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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Kilo343 page 1 of 5

MAR 1 1 2011

SECTION 5: 510(k) Summary

Submitter

Mayborn Group Limited Northumberland Business Park (West) Dudley Lane Cramlington Northumberland United Kingdom NE23 7RH

Tel: +44 191 250 1864 Fax: +44 191 250 1727 Owner/Operator Number: Establishment Registration No.: 10034113

Contact Person

Neil Hewitt Senior Quality Manager, Mayborn Baby & Child Division Northumberland Business Park (West) Dudley Lane Cramlington Northumberland United Kingdom NE23 7RH

Phone Number + 44 1912501864 Fax Number: +44 1912501727 E-mail Address nhewitt@jackel.co.uk

Date Prepared

December 2010

Device Information

Trade name: closer to nature® Common name: electric breast pump Classification Name: pump, breast, powered Review Panel: Obstetrics/Gynecology Product Code: HGX Device Class: 2

Indication for Use

Tommee Tippee Closer to Nature® Electric Breast Pump is used to express and collect milk from the breast of a lactating woman.

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Device Description

Included with the pump and vacuum system is:

Accessories

Sterilizer box - This doubles up as a storage case

Feeding Components

Feeding bottle with slow flow teat 2 Milk storage pots Milk storage lid 6 Breast pads

Devices to which substantial equivalence is claimed:

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Device Comparison to Legally Marketed Device

Below is a comparison chart outlining differences and similarities between the Tommee Tippee® Closer to Nature® Electric Breast Pump, and the Medela AG, SwingTM electric breast pump.

	New Product	The Predicate
Device Name	Tommee Tippee® Closer toNature®	SwingTM
Manufacturer	Mayborn Group Limited	Medela AG
510(k) number	To be assigned	K053052
Product Code	HGX	HGX
Classification	2	2

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	New Product	The Predicate
Intended use	As described in 21 CFR 884.5160	As described in 21 CFR 884.5160
Power Source	6V DCfour (4) AA batteries or electricadaptor	6V DCfour (4) AA batteries or electric adaptor
Pump type	Reciprocating Diaphragm	Reciprocating Diaphragm
Single or DoublePumping	Single	Single
Adjustable SuctionLevels	Yes - 4 Separate Speed Rates	Yes
Adjustable CycleSpeed	No	Yes
OverflowProtection	No	No
Highest VacuumSetting [in Hg]	10.6	11.8
Lowest VacuumSetting [in Hg.]	5.3	1.7
Range of CycleSpeeds	41 Fixed	45-72
Breast Cup-to-Breast Interface	Soft Silicone Wacker R401	Rigid Plastic with Soft TPE section

Both The Medala Swing (K053052) and the Closer to Nature Electric Breast Pump are identified by the FDA as Product code HGX under CFR section 884.5160.

Both Units use a standard 6v battery supply or mains adaptor.

Both units use a single diaphragm pump.

Both units generate a vacuum equivalent to approx 11 inches of Mercury on the maximum setting.

Key Areas

Mayborn Baby and Child during the development of the product identified five key comparative areas which would ensure the safety and integrity of the Closure to Nature Electric Breast Pump would match or exceed the ability of the Medela Swing (K053052)

These cover the following:

1. Pump vacuum direct measurement of the pumps used
1. Pump vacuum when installed in the housing
1. Lowest suction rate
1. Suction rate
1. Materials

The first key comparative area identified was the bare vacuum capability of the pumps when removed from the housing. A direct comparison of the pumps was carried out and the results

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K110343 page 4 of 5

showed the Closer to Nature pump drawing a vacuum of -40kpa and the Medala Swing pump drawing a vacuum of -38kpa.

This shows there is no significant difference in the devices.

The second key comparative area identified was the vacuum capability of the pumps when installed in the housing. A direct comparison of the pumps was carried out and the results showed the Closer to Nature Electric Breast Pump was capable of drawing a vacuum up to -38kpa and the Medala Swing pump was capable of drawing a vacuum up to -36kpa.

This shows there is no significant difference in the devices.

The third key comparative area identified was the lowest vacuum capability of the pumps when installed in the housing and the pump is set up for simulated use. A direct comparison of the pumps was carried out and the results showed the Closer to Nature pump drawing a vacuum of -20kpa and the Medala Swing pump drawing a vacuum of -29kpa.

This shows the Closer to Nature Electric Breast Pump can draw a slightly lower vacuum during use by the mother.

The forth key comparative area identified was the suction rate of the pump in terms of its ability to flow liquid. The comparison of the pumps identified the following:

Closer to Nature Electric Breast Pump: Time period = 2 minutes (120seconds) Fluid Displaced = 180millilitres

Medala Swing Electric Breast Pump: Time period = 2 minutes (120seconds) Fluid Displaced = 150millilitres

This shows there is no significant difference in the devices.

The fifth key area identified was material selection; all the materials specified and tested for use in the Closer to Nature Electric Breast Pump have been selected to ensure they meet the appropriate FDA regulations concerning food contact and or bio compatibility to ensure maximum protection of the infant from contaminated food and maximum comfort for the mother.

All milk and human contact components are manufactured from materials that meet FDA food additive criteria as set forth in Part 21 Code of Federal Regulations Parts 176, 177 and 178.

The skin contacting materials associated with the Electric Breast Pump will satisfy all required biocompatibility testing conducted in accordance with ISO 10993 for skin contact.

This shows there is no significant difference in the devices.

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K110343 page 5 of 5

Conclusion

Tommee Tippee® Closer to Nature® Electric Breast Pump, subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. Device presents no adverse health effects or safety risks when used as intended.

Tommee Tippee® Closer to Nature® Electric Breast Pump has the same intended use and fundamental scientific technology as its predicate device - the Medela® SwingTM Breast Pump (K053052).

Tommee Tippee® Closer to Nature® Electric Breast Pump was tested against its predicate, and was found to be substantially equivalent based on the summary information above and the detailed evaluation within this submission.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mayborn Group Limited c/o Ms. Paula Wilkerson Senior Staff Engineer - Medical Devices Intertek 2307 E Aurora Road, Unit B7 TWINSBURG OH 44087

MAR 1 1 20il

Re: K110343

Trade Name: Closer to Nature® Electric Breast Pump Regulation Number: 21 CFR $884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product code: HGX Dated: March 2, 2011 Received: March 4, 2011

Dear Ms. Wilkerson:

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/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,

Hubert Lenoir MD

Herbert 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

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SECTION 4: Indications for Use

510(k) Number: FBA KII0343

Device Name: Closer to Nature® Electric Breast Pump

Indications for Use:

Tommee Tippee® Closer to Nature® Electric Breast Pump is used to express and collect milk from the breast of a lactating woman.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices

510(k) Number	K110343
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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).