(29 days)
Tommee Tippee® Closer to Nature® Single Electric Breast Pump is personnel use item for lactating women and is intended for one user to express and collect milk from the breast.
This Single Electric Breast Pump product is designed to provide everything a mother will need to start expressing, storing and feeding. The pump unit has 4 alternate settings of sucction level during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2oz pod, which fits into "Closer to Nature" lottles 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.
The provided text is a 510(k) Summary for the Tommee Tippee Closer to Nature Single Electric Breast Pump, aiming to prove substantial equivalence to predicate devices (K110343 and K113664), not to meet acceptance criteria in the sense of a clinical trial for a new medical device with performance endpoints. Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is largely not applicable to this type of document.
This submission focuses on comparing the new device against existing, legally marketed predicate devices to demonstrate that it operates in a similar manner and does not raise new questions of safety or effectiveness. The "studies" conducted are comparative performance tests rather than clinical trials with patient outcomes.
However, I can extract the comparative data and present it in a table format, interpreting the "acceptance criteria" as the performance of the predicate device, and the "reported device performance" as the new product's performance.
Here's the information derived from the provided text, addressing your points where applicable:
1. Table of Acceptance Criteria (Predicate Device Performance) and Reported Device Performance
For this 510(k) submission, the "acceptance criteria" are not explicitly stated as numerical thresholds that must be met. Instead, the new device's performance is compared directly to its predicate device (Tommee Tippee Closer to Nature Single Electric Breast Pump, K110343, and in some cases, K113664 for the backflow). The goal is to show "no significant difference" or "significant improvement" where relevant.
| Performance Area | Predicate Device (K110343) Performance (Acceptance Criteria) | New Product (K121322) Reported Performance | Conclusion (as per submission) |
|---|---|---|---|
| Vacuum (Single Pumping) | |||
| Setting 1 | Stimulation | Stimulation | No significant difference |
| Setting 2 | 135mmHg | 150mmHg | No significant difference |
| Setting 3 | 205mmHg | 220mmHg | No significant difference |
| Setting 4 | 269mmHg (REF 510K) | 233mmHg | No significant difference |
| Suction Flow Rate | |||
| Setting 2 | 87ml/min | 88ml/min | No significant difference |
| Setting 3 | 122ml/min | 118ml/min | No significant difference |
| Setting 4 | 131ml/min | 131ml/min | No significant difference |
| Noise Level | |||
| Setting 4 (highest suction) | 68dba | 68dba | No significant difference |
| Materials | Predicate materials met FDA food additive criteria and biocompatibility (ISO 10993 parts 5 & 10 for skin contact). | New product materials meet FDA food additive criteria and biocompatibility (ISO 10993 parts 5 & 10 for skin contact). | No significant difference (both meet standards) |
| Electrical Safety | Predicate tested to IEC 60601-1:1988+A1:1991+A2:1995, UL 60601-1, and IEC 60601-1-2:2001+A1:2004. | New product (unit and adaptor) has the same electrical construction as predicate and is tested to the same applicable standards. | No significant difference (both meet standards) |
| Backflow Protection | No explicit backflow protection mechanism mentioned, implied that it could occur based on the new device's improvement. | New diaphragm system created a physical barrier stopping all backflow into the vacuum tube (same as K113664). | Significant improvement over K110343 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of number of devices tested for each performance characteristic. The tests appear to be conducted on "the new product" and "the predicate" (singular), implying a single unit or a small, unspecified number of units for engineering characterization.
- Data Provenance: The tests were conducted internally by Mayborn Baby and Child during product development. This is non-clinical, in-house testing. The country of origin of the data is not explicitly stated beyond Mayborn Group Limited being based in the United Kingdom. Given the nature of a 510(k) for a breast pump, this would be prospective laboratory/bench testing, not retrospective human data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. "Ground truth" in the context of clinical expert consensus (as with medical imaging or diagnostic devices) is not relevant here. The "ground truth" for these tests is the physical measurement of performance parameters (vacuum, flow rate, noise, material properties, electrical safety, backflow) of the devices themselves, performed using standard engineering and laboratory methods.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process for these physical performance tests. The results are direct measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is relevant for diagnostic devices where multiple human readers interpret medical cases. This submission is for a breast pump, and the "studies" are engineering performance comparisons, not human clinical effectiveness studies. Therefore, there is no effect size related to human readers improving with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
Not applicable. This is not an AI/algorithm-based device. The device's performance is its inherent physical function.
7. The Type of Ground Truth Used
The "ground truth" for the performance comparisons was based on:
- Physical measurements of vacuum, flow rate, and noise.
- Material testing against FDA regulations and ISO 10993 standards (biocompatibility).
- Electrical safety testing against IEC and UL standards.
- Observational testing for backflow protection.
These are objective, quantifiable engineering and regulatory compliance assessments, not clinical "ground truth" like pathology or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
{0}------------------------------------------------
K1.21322 page 1 of 6
MAY 3 1 2012
Product Closer to Nature – Single Electric Breast Pump – New Horn
Project File Number – DEV 1063 - update
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.: 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
March 2012
Device Information
| Trade name: | Closer to Nature |
|---|---|
| Common name: | Single Electric Breast Pump |
| Classification Name: | Pump, breast, powered |
| Review Panel: | Obstetrics / Gynecology |
| Product Code: | HGX |
| Device Class: | 2. |
Issue Number: Original
Date Effected: April 2012
Page 11 of 52
{1}------------------------------------------------
Dage Zot, K121322
2 of 52
MAYBO
510K Submission
Product Closer to Nature – Single Electric Breast Pump – New Horn
Project File Number - DEV 1063 - update
Indication for Use
Tommee Tippee® Closer to Nature® Single Electric Breast Pump is personnel use item for lactating women and is intended for one user to express and collect milk from thre breast.
Device Description
This Single Electric Breast Pump product is designed to provide everything a mother will need to start expressing, storing and feeding. The pump unit has 4 alternate settings of sucction level during expression. The collect and protect breast milk storage system enables the user to express directly into the small graduated 2oz pod, which fits into "Closer to Nature" lottles 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 Single electric breast pump motor unit and vacuum system are:
1 off - Feeding bottles 5oz with teats - as per Mayborn Single Electric Breast Pump - K110343
1 off - Milk storage lids - as per Mayborn Single Electric Breast Pump - K110343
2 off - Milk storage pods as per Mayborn Single Electric Breast Pump - K110343
6 off - Disposable Breast pads - as per Mayborn Single Electric Breast Pump -- K110343
1 off - Spare valves - K113664
1 off - Hygiene cover - as per Mayborn Single Electric Breast Pump - K110343
1 off - Steri Box - K110343
| Issue Number: Original | Date Effected: April 2012 | Page |
|---|---|---|
| ------------------------ | --------------------------- | ------ |
{2}------------------------------------------------
K121 322 page 30f6
MAYBO ABY AND CHILD
510K Submission
Product Closer to Nature – Single Electric Breast Pump – New Horn
Project File Number – DEV 1063 - update
Devices to which substantial equivalence is claimed:
| 510(k) number | Trade or propriety name |
|---|---|
| K110343 | Tommee Tippee Closer to Nature Single Electric Breast Pump |
| K113664 | Tommee Tippee Closer to Nature Double Electric Breast Pump |
Device Comparison to Legally Marketed Device
Following is a comparison chart outlining differences and similarities between the new Tomme Tippee Closer to Nature Single Electric Breast Pump, and the Current Timmee Tippee Closer To Nature Electric Breast Pump cleared under 510k K110343 and K113664.
| New Product | Predicate | Predicate | |
|---|---|---|---|
| Device Name | Tommee Tippee Closer toNature Single Electric BreastPump | Tommee Tippee Closer toNature Single Electric BreastPump | Tommee Tippee Closer toNature Double Electric BreastPump |
| Manufacturer | Mayborn Group Limited | Mayborn Group Limited | Mayborn Group Limited |
| 510(k) number | To be assigned | K110343 | K113664 |
| Product Code | HGX | HGX | HGX |
| Classification | 2 | 2 | 2 |
| Intended use | As described in 21 CFR884.5160 | As described in 21 CFR884.5160 | As described in 21 CFR884.5160 |
| Power Source | 5V DCElectrical Adaptor OR 4 x AABatteries | 5V DCElectrical Adaptor OR 4 x AABatteries | 9V DCElectrical Adaptor OR Battery |
| Pump type | Reciprocating Diaphragm | Reciprocating Diaphragm | Reciprocating Diaphragm |
| Single Pumping | Single | Single | Single |
| Suction Levels | Yes - 1 Pre set on startingand 3 User SelectableSeparate Speed Rates | Yes - 1 Pre set on starting and3 User Selectable SeparateSpeed Rates | Yes - 1 Pre set on starting and4 User Selectable SeparateSpeed Rates |
| Highest VacuumSetting - singlepump | 233mmHg | 269mmHg | 300mmhg |
| Lowest VacuumSetting - singlepump | 150mmHg | 135mmHg | 150mmHg |
| AdjustableCycle Speed | No | No | No |
| Range of CycleSpeeds | 36 | 41 | 36 |
| OverflowProtection | Yes | No | Yes |
| Breast Cup-to-Breast Interface | Soft Silicone Wacker R401and Toshiba TSE 260 | Soft Silicone Wacker R401 | Soft Silicone Wacker R401 andToshiba TSE 260 |
Issue Number: Original
Date Effected: April 2012
{3}------------------------------------------------
Product Closer to Nature - Single Electric Breast Pump - New Horn
Project File Number - DEV 1063 - update
Both of the Current Tommee Tippee Closer To Nature Electric Breast Pumps (K110343 & K113664) and the new Closer to Nature Single Electric Breast Pump are identified by the FDA as Product code HGX under CFR section 884.5160.
Both Units use batteries or mains adaptor.
Both units use a single diaphragm / piston pump.
The Horn (DEV 1063-4) used on the current Closer to Nature Breast Pumps K110343 and K113664 has been utilised on the new Closer to Nature Bingle Electric Pumps and is the approved with respect to biocompatibility.
Non Clinical Testing
Mayborn Baby and Child during the development of the product identified six key comparative areas which would ensure the safety and integrity of the new Closure to Nature Single Electic Breast Pump would match or exceed the ability of the Current Tommee Tippee Closer To Nature Single Electric Breast Pump (K110343).
These cover the following:
-
- Pump vacuum when installed in the housing mmHg
-
- Suction flow rate millilitres per minute
-
- Noise Level decibel level
-
- Materials
-
- Electrical Safety.
-
- Backflow protection
1. Pump vacuum when installed in the housing
The first key comparative area identified was the vacuum capability of the pump when installed in the housing. A direct comparison of the pumps was carried out as below.
Vacuum While Single Pumping
| New Product | The Predicate | |
|---|---|---|
| Device Name | Tommee Tippee Closer to Nature | K110343 |
| Setting 1 | Stimulation | |
| Setting 2 | 150mmHg | 135mmHg |
| Setting 3 | 220mmHg | 205mmHg |
| Setting 4 | 233mmHg | 269mmHg (REF 510K) |
This shows there is no significant difference in the devices.
| Issue Number: Original |
|---|
| Date Effected: April 2012 |
| Page 14 of 52 |
{4}------------------------------------------------
Product Closer to Nature - Single Electric Breast Pump - New Horn
Project File Number - DEV 1063 - update
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, this test used a newly design flow rate fixture to that used in the original breast pump submission. The comparison of the pumps identified the following:
Single Pump
| Device Name | New Product | The Predicate |
|---|---|---|
| Setting 1 | Stimulation | |
| Setting 2 | 88ml/min | 87ml/min |
| Setting 3 | 118ml/min | 122ml/min |
| Setting 4 | 131ml/min | 131ml/min |
| Device Name | Tommee Tippee Closer to Nature | K110343 |
All tested on high suction over duration of 2 minutes 30 seconds. Reservoir water level was maintained at 3 litres. CTN Fast Flow teats used in rig.
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, midle and highest settings.
| New Product | The Predicate | |
|---|---|---|
| Device Name | Tommee Tippee Closer to Nature | K110343 |
| Setting 4 | 68dba | 68dba |
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 new Closer to Nature Single 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 Single 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.
| Issue Number: Original | Date Effected: April 2012 | Page 15 of 52 |
|---|---|---|
| ------------------------ | --------------------------- | --------------- |
{5}------------------------------------------------
K12132Z
510K Submission
Product Closer to Nature – Single Electric Breast Pump – New Horn
Project File Number - DEV 1063 - update
5. Electrical Safety
The fifth key comparative area identified was the Electrical safety of the. The unit and adaptor are the same electrical construction as the Current Tommee Tippee Closer To Nature Single Electric Breast Pump (K110343) which has been tested to the applicable standards below.
Applicable standards
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1: 1988 + A1: 1991 +A2: 1995 UL 60601-1, 1st edition, Rev April 26 2006
Medical electrical equipment - EMC (Electromagnetic Compatibility Requirements)
IEC 60601-1-2: 2001 + A1: 2004
6. Back flow Protection.
Both the new Closer to Nature Single Electric Breast Pump and the Current Tommee Tippee Closer To Nature Single Electric Breast Pump (K110343) were tested to determine the angle at which backflow into the vacuum tube could be created.
It was found that the new diaphragm system in the Closer to Nature Single Electric Breast Pump created a physical barrier which stopped all backflow into the vacuum tube this is a significant improvement in product reliability and eliminates the potential for miss use. This arti back flow system is the exact same system clear under 510K K113664 the Closer to Nature Double Electric Breast Pump
This shows the new Closer to Nature Single Electric Breast Pump has a significant improvement over the Current Tommee Tippee Closer To Nature Single Electric Breast Pump (K110343.)
Conclusion
The new Tommee Tippee Closer to Nature Single 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.
The new Tommee Tippee Closer to Nature Single Electric Breast Pump has the same intended use and fundamental scientific technology as its predicate device – the Current Tommee Tippee Closer To Nature Single and Double Electric Breast Pump (K110343 and K113664)
The new Tommee Tippee Closer to Nature Single 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.
| Issue Number: Original | Date Effected: April 2012 |
|---|---|
| Page 16 of 52 |
{6}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mayborn Group Limited % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW BUFFALO MN 55313
MAY 3 1 2012
Re: K121322
Trade/Device Name: Closer to Nature Single Electric Breast Pump Regulation Number: 21 CFR§ 884.5160 Regulation Name: Powered breast pump Regulatory Class: II Product Code: HGX Dated: May 17, 2012 Received: May 18, 2012
Dear Mr. Job:
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 Act. The Act. 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
{7}------------------------------------------------
Page 2 -
device-related 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,
Benjamin R. Fisher, Ph.D.
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
{8}------------------------------------------------
EAST AND CHILL
Product Closer to Nature - Single Electric Breast Pump - New Horn
Project File Number - DEV 1063 - update
SECTION 4: Indications for Use
510(k) Number:
K12/322
Device Name:
Closer to Nature Single Electric Breast Pump
Indications for Use:
Tommee Tippee® Closer to Nature® Single Electric Breast Pump is personnel use item for lactating women and is intended for one user to express and collect milk from the breast.
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)
ision Sign-Of of Reproductive. Gastro-Renal, a 510(k) Number
Page 1 of 1
Issue Number: Original Date Effected: April 2012 Page 10 of 52
§ 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).