(66 days)
No
The description focuses on mechanical and electrical components, suction levels, and milk storage. There is no mention of AI/ML terms, image processing, or data sets for training/testing.
No.
The device is used to express and collect milk from the breast. It does not treat or diagnose any medical condition.
No
The device is a breast pump, used to express and collect milk, which is a therapeutic or supportive function, not a diagnostic one.
No
The device description explicitly lists numerous hardware components, including a pump unit, bottles, storage pods, and a carry bag, indicating it is a physical device with accompanying accessories, not solely software.
Based on the provided information, the Tommee Tippee® Closer to Nature® Double Electric Breast Pump is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "express and collect milk from the breast of a lactating woman." This is a physical process involving the body, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details a mechanical pump and accessories for collecting and storing breast milk. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes) in samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition
- Using reagents or calibrators
The device is clearly designed for the physical act of expressing breast milk, which falls under the category of a medical device, but not specifically an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
HGX
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
breast
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)
Comparison charts were created to compare the subject device to the predicate device in terms of:
- Pump vacuum when installed in the housing
- Suction flow rate
- Noise Level
- Materials
Key results:
- Vacuum While Double Pumping: From Setting 1 to Setting 5, the subject device showed mbar values ranging from 160mbar to 330mbar. The predicate device showed mbar values from 120mbar to 220mbar for tested settings (1, 3, 5).
- Vacuum While Single Pumping: From Setting 1 to Setting 5, the subject device showed mbar values ranging from 240mbar to 450mbar. The predicate device showed mbar values from 200mbar to 330mbar for tested settings (1, 3, 5).
- Single Pump Suction Flow Rate: Subject device showed 80ml, 115ml, 145ml for settings 1, 3, 5 respectively. Predicate showed 108ml, 147ml, 160ml for settings 1, 3, 5 respectively.
- Double Pump Suction Flow Rate: Subject device showed LH 73ml/RH 65ml (Setting 1), LH 105ml/RH 95ml (Setting 3), LH 135ml/RH 125ml (Setting 5). Predicate showed LH 75ml/RH 80ml (Setting 1), LH 88ml/RH 103ml (Setting 3), LH 120ml/RH 135ml (Setting 5). All tested on high suction over 2 minutes 30 seconds.
- Noise Level: For settings 1, 3, 5, the subject device reported 64.3db, 63.4db, 63.7db respectively. The predicate device reported 62.6db, 62.5db, 63db for the same settings.
- Materials: All materials meet FDA food additive criteria (21 CFR Parts 176, 177, 178) and satisfy biocompatibility testing according to ISO 10993 parts 5 and 10.
Conclusion: "This shows there is no significant difference in the devices." for vacuum, suction flow rate, and noise level.
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.
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
K113664 page 1 of 7
SECTION 5: 510(k) Summary
Submitter
ﮨﮯ ﮨﮯ
r
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
1
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.
Device Description
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
2
K113664 page 3 of 1
Devices to which substantial equivalence is claimed:
510(k) number
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 Nature | |
| Double 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 CFR |
| 884.5160 | ||
| Power Source | 9 V DC | |
| Rechargeable 7.4V lithium | ||
| polymer battery or electric | ||
| adaptor | 9V DC | |
| 6 *1.2 V rechargeable batteries | ||
| or electric adaptor | ||
| Pump type | Reciprocating Diaphragm | Reciprocating Piston |
| Single or Double | ||
| Pumping | Single + Double | Single + double |
| Suction Levels | Yes - 1 Pre set on starting and 4 | |
| User Selectable Separate Speed | ||
| Rates | Variable | |
| Highest Vacuum | ||
| Setting - double | ||
| pump | 360mbar | 230mbar |
| Lowest Vacuum | ||
| Setting - double | 130mbar | 110mbar |
| Highest Vacuum | ||
| Setting - single | ||
| pump | 450mbar | 330mbar |
| Lowest Vacuum | ||
| Setting - single | ||
| pump | 200mbar | 190mbar |
| Adjustable Cycle | ||
| Speed | No | Yes - Variable |
| Range of Cycle | ||
| Speeds | Fixed | 30-60 cycles per minute |
| Overflow Protection | Yes | Yes |
| Breast Cup-to- | ||
| Breast Interface | Soft Silicone Wacker R401 and | |
| Toshiba TSE 260 | Hard PP |
3
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.
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:
-
- Pump vacuum when installed in the housing mbar
-
- Suction flow rate millilitres per minute
-
- Noise Level decibel level
-
- 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 |
4
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 73ml | |
| RH 65ml | LH 75ml | |
| RH 80ml | ||
| Setting 2 | ||
| Setting 3 | LH 105ml | |
| RH 95ml | LH 88ml | |
| RH 103ml |
5
K 113664 page 6 of 7
| Setting 4 | ||
|---|---|---|
| Setting 5 | LH 135ml | |
| RH 125ml | LH 120ml | |
| RH 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.
6
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.
7
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,
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
9
Image /page/9/Picture/0 description: The image shows the word "MAYBORN" in a bold, sans-serif font. The letter "O" in "MAYBORN" is represented by a circle. Below the word "MAYBORN", there is smaller text that reads "BABY AND CHILD".
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 |