This Double Electric Breast Pump product is designed to provide everything a mother will need to start expressing, storing and feeding. The pump unit has 5 alternate settings of suction level during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2oz or 4oz pod, which fits into "Closer to Nature" bottles for feeding. The product is designed to use, one pod size per 5oz bottle and 2 pod sizes for a 9oz bottle for expressing, storing and feeding. This device is mains or battery powered.

Included with the double electric breast pump motor unit and vacuum system are:

1 off Carry Bag to hold pump and accessories
2 off Feeding bottles 5oz with teats as per Mayborn Single Electric Breast Pump K110343
2 off Feeding bottles 9oz without teats
4 off Milk storage lids as per Mayborn Single Electric Breast Pump K110343
2 off 4oz Milk storage pods
4 off 2oz Milk storage pods as per Mayborn Single Electric Breast Pump K110343
1 off Milk storage pod tray
1 off Bottle bag for feeding bottles with milk storage lid
6 off Disposable Breast pads as per Mayborn Single Electric Breast Pump K110343
2 off Spare valves
2 off Spare Diaphragms
2 off - Hygiene cover - as per Mayborn Single Electric Breast Pump - K110343

AI/ML Overview

The provided text describes the 510(k) summary for the Tommee Tippee Closer to Nature Double Electric Breast Pump (K113664), demonstrating substantial equivalence to a predicate device, the Ameda Purely Yours Ultra (K973501).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly defined as pass/fail thresholds in the document. Instead, the study focuses on demonstrating substantial equivalence to the predicate device by comparing key performance parameters. The "acceptance" can be inferred as showing "no significant difference" or comparable performance to the predicate.

Performance Characteristic	Acceptance Criteria (Implicit: Comparable to Predicate)	Reported Device Performance (Tommee Tippee Closer to Nature)	Predicate Device Performance (Ameda Purely Yours Ultra)
Vacuum - Double Pumping	No significant difference from predicate	Setting 1: 160mbar Setting 3: 260mbar Setting 5: 330mbar	Setting 1: 120mbar Setting 3: 180mbar Setting 5: 220mbar
Vacuum - Single Pumping	No significant difference from predicate	Setting 1: 240mbar Setting 3: 380mbar Setting 5: 450mbar	Setting 1: 200mbar Setting 3: 280mbars Setting 5: 330mbar
Suction Flow Rate - Single Pump (ml, 2 min 30 sec)	No significant difference from predicate	Setting 1: 80ml Setting 3: 115ml Setting 5: 145ml	Setting 1: 108ml Setting 3: 147ml Setting 5: 160ml
Suction Flow Rate - Double Pump (ml, 2 min 30 sec)	No significant difference from predicate	Setting 1: LH 73ml, RH 65ml Setting 3: LH 105ml, RH 95ml Setting 5: LH 135ml, RH 125ml	Setting 1: LH 75ml, RH 80ml Setting 3: LH 88ml, RH 103ml Setting 5: LH 120ml, RH 135ml
Noise Level (dB)	No significant difference from predicate	Setting 1: 64.3db Setting 3: 63.4db Setting 5: 63.7db	Setting 1: 62.6db Setting 3: 62.5db Setting 5: 63db
Materials	Meets FDA food additive criteria and biocompatibility	All milk/human contact components meet FDA 21 CFR 176, 177, 178. Skin contact materials satisfy ISO 10993 parts 5 and 10.	(Implicit: Predicate also meets these standards)

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify the sample size for the test set. The data appears to be from a retrospective comparison as part of the 510(k) submission process, comparing the newly developed device against a legally marketed predicate device. The provenance of the data is not explicitly stated beyond being measurements taken for the "Tommee Tippee Closer to Nature" device and the "Ameda Purely Yours Ultra" predicate. It is likely that the measurements for the Tommee Tippee device were performed by Mayborn Group Limited (United Kingdom) or a contracted lab. The source of the predicate device's performance data is not detailed but would typically come from publicly available specifications or testing by the submitter of the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information (number of experts, their qualifications, and ground truth establishment) is not applicable to this submission. The study is a physical and technical comparison of device performance characteristics (vacuum, flow rate, noise, materials) against a predicate, not clinical performance based on expert interpretation of results (e.g., image analysis, diagnostic accuracy).

4. Adjudication Method for the Test Set

This is not applicable as the comparisons are based on objective physical measurements, not subjective evaluations requiring adjudication.

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

This is not applicable. This is a medical device comparison based on physical performance and material safety, not a study involving human readers, AI assistance, or clinical effectiveness in that context.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

This is not applicable. There is no algorithm or AI component in this breast pump.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is the measured physical properties and characteristics of both the new device and the predicate device. For the materials, the ground truth is defined by FDA regulations for food contact and ISO 10993 standards for biocompatibility. These are objective, measurable standards, not subject to expert consensus or pathology.

8. The Sample Size for the Training Set

This is not applicable. There is no training set as this is not a machine learning or AI-based device.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there is no training set.

Summary

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K113664 page 1 of 7

SECTION 5: 510(k) Summary

Submitter

ﮨﮯ ﮨﮯ

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 .: 3008729914

Contact Person

Neil Hewitt Global Quality Manager, Mayborn Baby & Child Division Northumberland Business Park (West) Dudley Lane Cramlington Northumberland United Kingdom NE23 7RH Phone Number + 44 191 250 1864 Fax Number: +44 191 250 1727 E-mail Address nhewitt@jackel.co.uk

Date Prepared

29th October 2011

Device Information

Trade name:	Closer to Nature
Common name:	Double Electric Breast Pump
Classification Name:	Pump, breast, powered
Review Panel:	Obstetrics / Gynecology
Product Code:	HGX
Device Class:	2

FEB. 1 7 2012

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Indication for Use

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

K113664

Device Description

Included with the double electric breast pump motor unit and vacuum system are:

1 off Carry Bag to hold pump and accessories
2 off Feeding bottles 5oz with teats as per Mayborn Single Electric Breast Pump K110343
2 off Feeding bottles 9oz without teats
4 off Milk storage lids as per Mayborn Single Electric Breast Pump K110343
2 off 4oz Milk storage pods
4 off 2oz Milk storage pods as per Mayborn Single Electric Breast Pump K110343
1 off Milk storage pod tray
1 off Bottle bag for feeding bottles with milk storage lid
6 off Disposable Breast pads as per Mayborn Single Electric Breast Pump K110343
2 off Spare valves
2 off Spare Diaphragms

2 off - Hygiene cover - as per Mayborn Single Electric Breast Pump - K110343

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K113664 page 3 of 1

Devices to which substantial equivalence is claimed:

510(k) number

K973501

Trade or propriety name Ameda Purely Yours Ultra

Device Comparison to Legally Marketed Device

Following is a comparison chart outlining differences and similarities between the Tommee Tippee Closer to Nature Double Electric Breast Pump, and the Ameda Purely Yours Ultra.

	New Product	Predicate
Device Name	Tommee Tippee Closer to NatureDouble Electric Breast Pump	Purely Yours Ultra
Manufacturer	Mayborn Group Limited	Ameda / Evenflo
510(k) number	To be assigned	K973501
Product Code	HGX	HGX
Classification	2	2
Intended use	As described in 21 CFR 884.5160	As described in 21 CFR884.5160
Power Source	9 V DCRechargeable 7.4V lithiumpolymer battery or electricadaptor	9V DC6 *1.2 V rechargeable batteriesor electric adaptor
Pump type	Reciprocating Diaphragm	Reciprocating Piston
Single or DoublePumping	Single + Double	Single + double
Suction Levels	Yes - 1 Pre set on starting and 4User Selectable Separate SpeedRates	Variable
Highest VacuumSetting - doublepump	360mbar	230mbar
Lowest VacuumSetting - double	130mbar	110mbar
Highest VacuumSetting - singlepump	450mbar	330mbar
Lowest VacuumSetting - singlepump	200mbar	190mbar
Adjustable CycleSpeed	No	Yes - Variable
Range of CycleSpeeds	Fixed	30-60 cycles per minute
Overflow Protection	Yes	Yes
Breast Cup-to-Breast Interface	Soft Silicone Wacker R401 andToshiba TSE 260	Hard PP

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Both the Ameda Purely Yours Ultra and the Closer to Nature Double Electric Breast Pump are identified by the FDA as Product code HGX under CFR section 884.5160.

K113664

Both Units use a rechargeable batteries or mains adaptor.

Both units use a single diaphragm / piston pump.

The Horn (DEV 1063-4) is used on the Closer to Nature Single Breast Pump K110343 and has been utilised on the Closer to Nature Double Electric Pump and is the approved with respect to biocompatibility.

Key Areas

Mayborn Baby and Child during the development of the product identified four key comparative areas which would ensure the safety and integrity of the Closure to Nature Double Electric Breast Pump would match or exceed the ability of the Ameda Purely Yours Ultra.

These cover the following:

1. Pump vacuum when installed in the housing mbar
1. Suction flow rate millilitres per minute
1. Noise Level decibel level
1. Materials

1. Pump vacuum when installed in the housing

The first 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 as below.

Vacuum While Double Pumping

Device Name	Tommee Tippee Closer to Nature	Purely Yours Ultra
Setting 1	160mbar	120mbar
Setting 2	210mbar	Not tested - as variable
Setting 3	260mbar	180mbar
Setting 4	300mbar	Not tested - as variable
Setting 5	330mbar	220mbar
Setting 6
Setting 7
Setting 8
Setting 9

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Vacuum While Single Pumping

Device Name	Tommee Tippee Closer to Nature	Purely Yours Ultra
Setting 1	240mbar	200mbar
Setting 2	320mbar	Not tested - as variable
Setting 3	380mbar	280mbars
Setting 4	420mbar	Not tested - as variable
Setting 5	450mbar	330mbar
Setting 6
Setting 7
Setting 8
Setting 9

This shows there is no significant difference in the devices.

2. Suction flow rate

The second 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:

· Single Pump

Device Name	Tommee Tippee Closer to Nature	Purely Yours Ultra
Setting 1	80ml	108ml
Setting 2	Not tested	Not tested
Setting 3	115ml	147ml
Setting 4	Not tested	Not tested
Setting 5	145ml	160ml
Setting 6

Double Pump

Device Name	Tommee Tippee Closer to Nature	Purely Yours Ultra
Setting 1	LH 73mlRH 65ml	LH 75mlRH 80ml
Setting 2
Setting 3	LH 105mlRH 95ml	LH 88mlRH 103ml

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K 113664 page 6 of 7

Setting 4
Setting 5	LH 135mlRH 125ml	LH 120mlRH 135ml
Setting 6

All tested on high suction with both pumps attached over duration of 2 minutes 30 seconds. Reservoir water level was maintained at 3 litres.

CTN Fast Flow teats used in rig.

Double CTN was tested without the top of the pump attached.

This shows there is no significant difference in the devices.

3. Noise Level

The third key comparative area identified was the noise level of the pump in terms of being discreet. The comparison of the pumps identified the following based on the lowest, middle and highest settings.

Device Name	Tommee Tippee Closer to Nature	Purely Yours Ultra
Setting 1	64.3db	62.6db
Setting 2
Setting 3	63.4db	62.5db
Setting 4
Setting 5	63.7db	63db
Setting 6

This shows there is no significant difference in the devices

4. Materials

The fourth key area identified was material selection; all the materials specified and tested for use in the Closer to Nature Double Electric Breast Pump have been selected to ensure they meet the appropriate FDA regulations concerning food contact and or biocompatibility 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 Double Electric Breast Pump satisfy all required biocompatibility testing in accordance with ISO 10993 parts 5 and 10 for skin contact.

This shows there is no significant difference in the devices.

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K 113664 p

Conclusion

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

Tommee Tippee Closer to Nature Double Electric Breast Pump has the same intended use and fundamental scientific technology as its predicate device - the Ameda Purely Yours Ultra Breast Pump (K973501).

Tommee Tippee Closer to Nature Double 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/7/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Mayborn Group Limited % Ms. Paula Wilkerson Medical Device Program Manager - Intertek 3rd Party Program Intertek 2307 East Aurora Rd. Unit B7 TWINSBURG OH 44087

FEB 1 7 2012

Re: K113664

Trade/Device Name: Closer to Nature Double Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: January 31, 2012 Received: February 6, 2012

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 10 ass started in the enactment date of 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 I ou mayy are croy isions 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 r lease be actived that i Drive interest on that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I carrater stations the requirements, including, but not limited to: registration and listing రంగipy with and 7); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{8}------------------------------------------------

Page 2-

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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,

Benjamin K. Evans

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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510K Submission

Product Closer to Nature – Double Electric Breast Pump

Project File Number – DEV 1092

SECTION 4: Indications for Use

113664 510(k) Number:

Device Name:

Closer to Nature Double Electric Breast Pump

Indications for Use:

Tommee Tippee® Closer to Nature® Double 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)
Division Sign-Off		Page 1 of 1
Division of Reproductive, Gastro-Renal, and
Biological Devices
510(k) Number	K113664
	Issue Number: Original	Date Effected: 29th October 2011	Page 9 of 55

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).