(120 days)
Not Found
No
The document describes a standard electric breast pump with different pressure settings and power options. There is no mention of AI, ML, or any features that would suggest adaptive learning, image processing, or complex data analysis beyond basic electronic control. The performance testing focuses on pressure and battery life, not algorithmic performance.
No
The device is described as a breast pump intended for lactating women to express and collect milk, which is a supportive rather than a therapeutic function.
No
The device is a breast pump, intended for lactating women to express and collect milk, and its description focuses on mechanical function rather than on diagnosing any medical condition.
No
The device description explicitly lists multiple hardware components (pump, breast shields, tubing, power cord, bottle and cap, valve, carrying bag) and describes the device as an "electronically powered suction device." While it mentions being "software driven," it is clearly a physical device with software controlling its operation, not a software-only device.
Based on the provided text, the Nature's Bond 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 their breasts to complement breast feeding." This is a physical process involving the body, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a mechanical device that applies suction to the breast. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly described as a breast pump, which is a medical device used for a therapeutic or supportive purpose, not a diagnostic one.
N/A
Intended Use / Indications for Use
Nature's Bond breast pump is a single user device intended for lactating women to express and collect milk from their breasts to complement breast feeding.
Product codes
HGX
Device Description
The Nature's Bond series of breast pumps are electriconically powered suction devices used to express and collect breast milk from lactating mothers. The Nature's Bond series is comprised of two pumps, the model 600 and the model 603. The Nature's Bond breast pump system consists the pump, breast shields, tubing, power cord, bottle and cap, valve, and carrying bag exclusively for the model 603.
All available accessories are included in the Nature's Bond 600/603 package. Customers may purchase additional accessories if needed. Below is a list of all accessories included in the package:
- 2*80mm Breast Shield
- 2*76mm Breast Shield
- 2*74mm Breast Shield
- 2*Bottle
- 2*Valve
- 1*Tubing
Both models of the Natuer's Bond breast pump is a software driven pump made from plastic. The details of the materials can be found in the bill of material. The pump can provide a pressure range from 0 mmHg to 206 mmHg. The model 603 has battery power (6 AA batteries) while the model 600 is only AC powered. While in using, the breast shields are in contact with human body. The device is design to be used by a single patient through one lactating period.
The device is designed for home use and is non-sterile.
Both pumps are the same in operation, use and design with the exception that the model 603 has the option to be battery powered. The pump provides intermittent suction in 6 different vacuum pressure settings to the breast to stimulate milk expression. The breast shields provide a seal around the breast to facilitate the suction. The bottles and caps are used to collect and store the milk. The tubing is used to connect the pump to the shields. The carrying bag is used to store all components when not in use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breasts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home use
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)
Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the Nature's Bond 600/603 are substantially equivalent to those of the predicate devices. The following tests were conducted to ensure Nature's Bond Breast Pump 600/603 meet their specifications.
- Nature's Bond 603 Battery Depreciation Test
- Breast Pump Performance Pressure Test
- One-Way Valve Test
During all above tests, the subject devices have software version 00.01, which is the version verified and validated in the software section.
Performance Testing was performed to compare the technological features of the two devices (subject and predicate), to show that the pressure at the breast shield was comparable between the subject and predicate devices. From this performance testing, it was found that the pressure applied to the breast through the breast shield of the subject device and the predicate device are comparable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which is a stylized representation of a human figure in profile, repeated three times and arranged in a way that suggests movement or progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 4, 2014
Devon Medical Products c/o Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K142168
Trade/Device Name: Nature's Bond 600, Nature's Bond 603 Regulation Number: 21 CFR 884.5160 Regulation Name: Powered breast pump Regulatory Class: Class II Product Code: HGX Dated: November 19, 2014 Received: November 20, 2014
Dear Mark 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 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
1
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 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Herbert P. Lerner -S
for
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142168
Device Name Nature's Bond 600 Nature's Bond 603
Indications for Use (Describe)
Nature's Bond breast pump is a single intended for lactating women to express and collect milk from their breasts to complement breast feeding.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
Submitter:
Devon Medical Products 1100 First Avenue, Suite 202 King of Prussia, PA 19406
Contact Person:
Ruth Wu, CCO Phone: 610.757.4103 Fax: 610.930.4035
Common Classification & Proprietary Names:
| Common Names: | Breast Pump |
|---|---|
| Proprietary Name: | Nature's Bond 600 |
| Nature's Bond 603 |
Date Prepared:
September 12th, 2014
Classification
The classification name, 21 CFR Part and Paragraph number, product code and classification of the Nature's Bond 600/603.
| Classification Name | 21 CFR
Section | Product
Code | Class |
|-----------------------|-------------------|-----------------|-------|
| Pump, Breast, Powered | 884.5160 | HGX | II |
Predicate Devices:
The Nature's Bond 600/603 Breast Pump is substantially equivalent to the following.
| Predicate Device | Manufacturer | 510(k)# |
|---|---|---|
| Powered Breast Pump | Lansinoh | K122474 |
Device Description
The Nature's Bond series of breast pumps are electriconically powered suction devices used to express and collect breast milk from lactating mothers. The Nature's Bond series is comprised of two pumps, the model 600 and the model 603. The Nature's Bond breast pump system consists the pump, breast shields, tubing, power cord, bottle and cap, valve, and carrying bag exclusively for the model 603.
All available accessories are included in the Nature's Bond 600/603 package. Customers may purchase additional accessories if needed. Below is a list of all accessories included in the package:
- . 2*80mm Breast Shield
- 2*76mm Breast Shield ●
- 2*74mm Breast Shield .
- 2*Bottle .
4
- 2*Valve .
- . 1*Tubing
Both models of the Natuer's Bond breast pump is a software driven pump made from plastic. The details of the materials can be found in the bill of material. The pump can provide a pressure range from 0 mmHg to 206 mmHg. The model 603 has battery power (6 AA batteries) while the model 600 is only AC powered. While in using, the breast shields are in contact with human body. The device is design to be used by a single patient through one lactating period.
The device is designed for home use and is non-sterile.
Both pumps are the same in operation, use and design with the exception that the model 603 has the option to be battery powered. The pump provides intermittent suction in 6 different vacuum pressure settings to the breast to stimulate milk expression. The breast shields provide a seal around the breast to facilitate the suction. The bottles and caps are used to collect and store the milk. The tubing is used to connect the pump to the shields. The carrying bag is used to store all components when not in use.
Indications For Use:
Nature's Bond breast pump is a single user device intended for lactating women to express and collect milk from their breasts to complement breast feeding.
Technological Characteristics:
Comparison
The manufacturer believes that the technological characteristics of the Nature's Bond 600/603 are substantially equivalent to those of the predicate devices.
The Nature's Bond 600/603 has very similar components to its predicate device and has same principles of operation. Both the predicate device and the Nature's Bond 600/603 consist of an electrically generated source of compressed air; tubing to convey the pressurized air to the flange. The flange is connected to a collection container to store the expressed milk just like the predicate devices. Both devices have two modes of suction to express milk and with similar pressure ranges of those modes. Performance Testing was performed to compare the technological features of the two devices (subject and predicate), to show that the pressure at the breast shield was comparable between the subject and predicate devices. From this performance testing, it was found that the pressure applied to the breast through the breast shield of the subject device and the predicate device are comparable.
| Feature | Nature's Bond
600/603 | Lansinoh
Powered Breast
Pump | Discussion of Differences |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Devon Medical
Products | Lansinoh | Different Manufacturers |
| FDA 510(k) | K142168 | K122474 | Different K #'s |
| Indications for | Nature's Bond breast | The Powered Breast | Same |
| Use | pump is a single user | Pump is intended to | |
| | | | |
| | device intended for
lactating women to
express and collect milk
from their breasts to
complement breast
feeding. | express and collect the
breast milk of a nursing
woman for the purpose
of feeding the collected
milk to a baby. The
Powered Breast Pump
is intended for a single
user. | |
| Single/Dual
Mode | Yes/Yes | Yes/Yes | Same |
| Internal
Construction | Pump, battery
(603 only), main
PCB, switch valve | Pump, battery,
main PCB, switch
valve | Same |
| Screen | LED Lights | LCD Display | Similar,
Though the Lansinoh has a LCD
display, and Nature's Bond utilizes
LED lights, the same information
is still provided to the user |
| Modes | 2 | 2 | Same |
| Stimulation
Mode | High Frequency,
Low Pressure | High Frequency,
Low Pressure | Same |
| Expression
Mode | Low Frequency,
High Pressure | Low Frequency,
High Pressure | Same |
| Max Measured
Vacuum
Pressure | 206.1 mmHg | 229.2 mmHg | Similar, The maximum vacuum
pressure is slightly lower on the
Nature's Bond than the Lansinoh,
which poses no harm. |
| Pump Style | DC Motor | DC Motor | Same |
| Energy Used | AC
Battery (603
Model) | AC
Battery | Same |
| Energy Used | AC & Battery (603
Model) | AC & Battery | Same |
| Materials Used | All food or human
contacting
components are
manufactured from
materials that
meet FDA food
additive criteria as
set forth in 21
Code of Federal
Regulations Part
176, 177, and 178 | All food or human
contacting
components are
manufactured from
materials that
meet FDA food
additive criteria as
set forth in 21
Code of Federal
Regulations Part
176, 177, and 178 | Same |
Determination of Substantial Equivalence
5
Section 5: 510(k) Summary
6
Section 5: 510(k) Summary
and ISO 10993 and ISO 10993
Food or Patient Contacting Parts
| Part | Contact |
|---|---|
| Breast Shield (Small, Medium, Large) | Patient Contact |
| Bottle | Food Contact |
| One-Way Valve | Food Contact |
Performance Testing
Bench and laboratory testing was performed and assures that the product meets its specifications. The manufacturer believes that the technological characteristics of the Nature's Bond 600/603 are substantially equivalent to those of the predicate devices. The following tests were conducted to ensure Nature's Bond Breast Pump 600/603 meet their specifications.
| Tests |
|---|
| Nature's Bond 603 Battery Depreciation Test |
| Breast Pump Performance Pressure Test |
| One-Way Valve Test |
During all above tests, the subject devices have software version 00.01, which is the version verified and validated in the software section.
The food contacting materials of the device are in compliance with 21 CFR 175.300, 177.1210, 177.1520, 177.1640, and 177.2600.
Standards
The Nature's Bond 600/603 conforms to the following standards:
IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN 60601-1-2:2007 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard:
AAMI ES 60601-1: 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices IEC 60601-1-11: General requirements for basic safety and essential performance -
Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
ISO 10079-1, Medical suction equipment Part 1: Electrically powered suction equipment -Safety requirements
ISO 10993-5 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity ISO 10993-10 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
ISO 10993-12 Biological evaluation of medical devices Part 12: Sample preparation and reference materials
7
Section 5: 510(k) Summary
ISO 10993-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ISO 10993-2:2006 Biological evaluation of medical devices -- Part 2: Animal welfare requirements ISO 10993-11:2006 Biological Evaluation of Medical Devices -- Part 11: Tests for Systemic Toxicity
Statement of Substantial Equivalence
The Nature's Bond 600/603 is substantially equivalent in technology, function, operating parameters, and intended use to predicate devices that are currently commercially available and in distribution, and does not raise any new questions of safety or effectiveness.
Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act and 21 CFR Part 807, and based on the information provided in this pre-market notification, Devon Medical Products, believes that the Nature's Bond 600/603, is substantially equivalent to the predicate devices as described herein.