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.

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.

AI/ML Overview

The provided text is a 510(k) summary for a breast pump, "Nature's Bond 600" and "Nature's Bond 603". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria based on clinical outcomes or a novel performance metric.

Therefore, the requested information, specifically acceptance criteria and a study proving the device meets those criteria, is not present in the document in the context of advanced AI/CAD system evaluation. The document describes performance testing performed to show comparability with the predicate device, which is a different type of evaluation.

However, I can extract information related to the device's technical specifications and how its performance was compared to a predicate device, which are analogous to certain aspects of acceptance criteria and performance reporting.

Here's what can be extracted and how it relates to your request:

1. A table of acceptance criteria and the reported device performance:

The document doesn't define explicit "acceptance criteria" in the sense of a clinical diagnostic study with sensitivity, specificity, etc. Instead, it relies on demonstrating substantial equivalence to a predicate device through technological characteristic comparison and bench testing.

Feature (Analogous to Acceptance Criteria)	Nature's Bond 600/603 (Reported Device Performance)	Predicate Device (Lansinoh Powered Breast Pump)	Comparison Outcome
Indications for Use	Single user device for lactating women to express and collect milk to complement breastfeeding.	Express and collect breast milk of a nursing woman for feeding to a baby. Intended for single user.	Same
Operating Modes	2 modes (Stimulation & Expression)	2 modes	Same
Stimulation Mode Characteristics	High Frequency, Low Pressure	High Frequency, Low Pressure	Same
Expression Mode Characteristics	Low Frequency, High Pressure	Low Frequency, High Pressure	Same
Max Measured Vacuum Pressure	206.1 mmHg	229.2 mmHg	Similar (slightly lower on Nature's Bond, "poses no harm"). This is the closest to a performance metric with a comparison.
Pump Style	DC Motor	DC Motor	Same
Energy Used	AC & Battery (603 Model), AC (600 Model)	AC & Battery	Same
Materials Used (Food/Human Contact)	Materials meet FDA food additive criteria (21 CFR Part 176, 177, 178)	Materials meet FDA food additive criteria (21 CFR Part 176, 177, 178)	Same
Software Version (during tests)	00.01	Not applicable (predicate is a physical product)	Verified and validated
Electrical Safety	Conforms to IEC 60601-1:2005, EN 60601-1-2:2007, AAMI ES 60601-1:2005, IEC 60601-1-11	Not explicitly stated for predicate in comparison table, but compliance to standards is generally required for all medical devices.	Implied equivalence through standard conformance.
Risk Management	Conforms to EN ISO 14971:2012	Not explicitly stated for predicate.	Implied equivalence through standard conformance.
Biocompatibility	Conforms to ISO 10993-5, -10, -12 (and other parts listed later)	Not explicitly stated for predicate.	Implied equivalence through standard conformance.
Food Contacting Materials Compliance	21 CFR 175.300, 177.1210, 177.1520, 177.1640, 177.2600	Not explicitly stated for predicate.	Implied equivalence through standard conformance.

The "study that proves the device meets the acceptance criteria" in this context is the Performance Testing described, which aimed to show the Nature's Bond 600/603 is substantially equivalent to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes bench and laboratory testing. This type of testing typically does not involve human subjects or patient data.
No sample size for a test set is mentioned because no clinical or human-subject study using a "test set" in the context of AI evaluation was performed. The "tests" refer to engineering and regulatory compliance assessments.
Data provenance is not applicable, as it's not a data-driven AI study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth in the sense of expert consensus for diagnostic accuracy was established as this is a mechanical breast pump, not an AI diagnostic device. The "ground truth" for compliance would be the technical specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication was performed.

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

Not applicable. This device is a breast pump, not an AI/CAD system, therefore, no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is a breast pump. While it has software, it is a physical product directly performing a function (milk expression). There is no "standalone algorithm" in the typical AI sense. The performance testing (e.g., pressure test, battery depreciation test) can be considered "standalone" in that they evaluate the device's technical functioning independent of a user, but this is a different context than AI performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this submission are the technical specifications of the device itself, relevant engineering standards (e.g., IEC, ISO), and FDA regulations (e.g., 21 CFR). The performance tests verify that the device operates according to its design specifications and complies with these standards and regulations.

8. The sample size for the training set

Not applicable. This document is for a physical medical device (breast pump), not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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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

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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

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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."

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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 CFRSection	ProductCode	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

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 .

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2*Valve .
. 1*Tubing

The device is designed for home use and is non-sterile.

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 Bond600/603	LansinohPowered BreastPump	Discussion of Differences
Manufacturer	Devon MedicalProducts	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 forlactating women toexpress and collect milkfrom their breasts tocomplement breastfeeding.	express and collect thebreast milk of a nursingwoman for the purposeof feeding the collectedmilk to a baby. ThePowered Breast Pumpis intended for a singleuser.
Single/DualMode	Yes/Yes	Yes/Yes	Same
InternalConstruction	Pump, battery(603 only), mainPCB, switch valve	Pump, battery,main PCB, switchvalve	Same
Screen	LED Lights	LCD Display	Similar,Though the Lansinoh has a LCDdisplay, and Nature's Bond utilizesLED lights, the same informationis still provided to the user
Modes	2	2	Same
StimulationMode	High Frequency,Low Pressure	High Frequency,Low Pressure	Same
ExpressionMode	Low Frequency,High Pressure	Low Frequency,High Pressure	Same
Max MeasuredVacuumPressure	206.1 mmHg	229.2 mmHg	Similar, The maximum vacuumpressure is slightly lower on theNature's Bond than the Lansinoh,which poses no harm.
Pump Style	DC Motor	DC Motor	Same
Energy Used	ACBattery (603Model)	ACBattery	Same
Energy Used	AC & Battery (603Model)	AC & Battery	Same
Materials Used	All food or humancontactingcomponents aremanufactured frommaterials thatmeet FDA foodadditive criteria asset forth in 21Code of FederalRegulations Part176, 177, and 178	All food or humancontactingcomponents aremanufactured frommaterials thatmeet FDA foodadditive criteria asset forth in 21Code of FederalRegulations Part176, 177, and 178	Same

Determination of Substantial Equivalence

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Section 5: 510(k) Summary

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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

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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.

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).