K Number
K241004
Device Name
Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
Date Cleared
2024-09-11

(152 days)

Product Code
Regulation Number
884.5160
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Wearable Breast Pump (ABP-1508PRO, ABP-1306, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.
Device Description
The Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping). The subject devices are capable of expression, stimulation, and auto modes with nine associated suction levels for each. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator displays. The pumps are powered by internal, non-replaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power. The breast pumps use cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the devices. The devices are capable of producing peak suction levels between -60 and -240 mmHg at speeds between 26 and 108 cycles per minute. There available pumping modes with 9 distinct levels of vacuum and cycle speed. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (silicone diaphragm) mechanism. All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.
More Information

Not Found

No
The description details preprogrammed modes and user-selected settings, with no mention of adaptive or learning capabilities.

No
The device is described as a powered breast pump used by lactating women to express and collect milk, which is not typically classified as a therapeutic device.

No

A diagnostic device is one that identifies a disease or condition. This device is a breast pump, used to express and collect milk, which is a functional purpose, not a diagnostic one.

No

The device description clearly outlines physical hardware components such as a DC motor, membrane vacuum pump, buttons, displays, and a rechargeable battery, indicating it is not a software-only device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
  • Device Function: The Wearable Breast Pump's intended use is to express and collect breast milk from lactating women. It is a mechanical device that applies suction to the breast.
  • No Testing on Samples: The device does not perform any tests on the collected breast milk or any other bodily fluid or tissue sample. It simply facilitates the collection process.

The provided information clearly describes a mechanical device for milk expression, not a diagnostic test performed on a sample.

N/A

Intended Use / Indications for Use

Wearable Breast Pump (ABP-1508PRO, ABP-1306, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.

Product codes (comma separated list FDA assigned to the subject device)

HGX

Device Description

The Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping).

The subject devices are capable of expression, stimulation, and auto modes with nine associated suction levels for each. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator displays. The pumps are powered by internal, non-replaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power.

The breast pumps use cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the devices. The devices are capable of producing peak suction levels between -60 and -240 mmHg at speeds between 26 and 108 cycles per minute. There available pumping modes with 9 distinct levels of vacuum and cycle speed. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (silicone diaphragm) mechanism

All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Breasts

Indicated Patient Age Range

Lactating women

Intended User / Care Setting

Single user, home environment

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)

Biocompatibility: Information was provided in accordance with Attachment G of the 2023 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process."

Electrical Safety: Testing was conducted in accordance with IEC 60601- 1 Edition 3.2 2020-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). IEC 6213-2:2017. Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems, and IEC 60601-1-11 Edition 3.1 2020-07 Medical electrical equipment - Part 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.

Electromagnetic Compatibility: Testing was conducted in accordance with IEC 60601-1-2:2014+A1: 2020 Medical Electrical Equipment -Part 1-2: "General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests."

Software: Software was evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document "Content of Premarket Submissions for Device Software Functions."

Performance Testing:

  • Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
  • Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
  • Use life testing was conducted to demonstrate that the device maintains its specifications throughout its proposed use life.
  • Battery performance testing was conducted to demonstrate that the battery remains functional during its stated battery use-life.
  • Battery status indicator testing was conducted to demonstrate that the battery status indicator remains functional during its stated battery life.

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.

K230102

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.

Not Found

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

September 11, 2024

HuiZhou LVB Maternal and Infant Supplies Co., Ltd. % Youshan Gong RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Oianhai Road Shenzhen, Guangdong 518052 CHINA

Re: K241004

Trade/Device Name: Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) Regulation Number: 21 CFR 884.5160 Regulation Name: Powered Breast Pump Regulatory Class: Class II Product Code: HGX Dated: August 12, 2024 Received: April 12, 2024

Dear Youshan Gong:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

1

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance/uniquedevice-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

2

(https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Monica D. Garcia -S

Monica D. Garcia, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K241004

Device Name

Wearable Breast Pump (ABP-1508PRO, ABP-1306, ABP-1306, ABP-1306, M1, M3, M8, M5, M6, K1, K2, K3, ABP-1306PLUS, ABP-1308, M2)

Indications for Use (Describe)

Wearable Breast Pump (ABP-1508PRO, ABP-1306, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K241004

1. Submitter Information

| Applicant: | HuiZhou LVB maternal and infant supplies
Co.,Ltd. |
|------------|-------------------------------------------------------------------------------------------------------------------|
| Phone: | 0752-2156859 |
| Address: | NO. 114,Xin Xing North Road, Sandong
Town, Huicheng District, Huizhou City,
Guangdong, Province, P.R. China |

2. Correspondent Information

| Contact: | Dongan Zhang
Head of Firm, |
|----------|-------------------------------|
| Email: | zhda7311@163.com |
| Phone: | 86 (13075) 210-606 |

3. Date prepared: September 5, 2024

4. Device Information

Device Name:Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2)
Common Name:Powered breast pump
Regulation Number:21 CFR 884.5160
Regulation Name:Powered Breast Pump
Product Code:HGX (Pump, Breast, Powered)
Regulatory Class:Class II

5. Predicate Device Information

Device Name:Wearable Breast Pump (ABP-1508)
510(k) Number:K230102
Manufacturer:Huizhou LVB Maternal And Infant Supplies Co,Ltd.

The predicate device has not been subject to a design-related recall.

6. Device Description

The Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is an electrically powered breast pump to be used in a home environment by a single user. The device is provided non-sterile and can be used on one breast (single pumping) or on both breasts at the same time (double pumping).

The subject devices are capable of expression, stimulation, and auto modes with nine associated suction levels for each. The subject devices feature various combinations of on/off buttons, level up/down buttons, mode selection buttons, suction level/time indicators, battery visual indicator displays. The pumps are powered by internal, non-replaceable, rechargeable lithium-ion batteries which are charged using the included AC power supply and cable. The subject device can be operated while plugged into AC power.

The breast pumps use cyclic negative pressure (suction) to mimic the suckling patterns of a feeding infant. A

5

DC motor drives a membrane vacuum pump to generate the suction required to stimulate and express breast milk. The timing of this pattern is dependent upon the suction/speed settings selected by the user and is preprogrammed in the devices. The devices are capable of producing peak suction levels between -60 and -240 mmHg at speeds between 26 and 108 cycles per minute. There available pumping modes with 9 distinct levels of vacuum and cycle speed. The subject device ensures backflow protection between the breast shield and the electronic components via a physical barrier (silicone diaphragm) mechanism

All other components (i.e., motor unit) of the subject device are not in contact with the breast. All milk contacting components are compliant with 21 CFR 174-179.

7. Indications for Use

Wearable Breast Pump (ABP-1508PRO, ABP-1306, ABP-1306, ABP-1306 PRO, M1, M3, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The device is intended for a single user.

8. Comparison of Intended Use and Technological Characteristics with the Predicate Device

The table below compares the intended use and technological characteristics of the subject and predicate device.

Table 1: Comparator Table for Subject and Predicate Devices

| | Wearable Breast Pump
(ABP-1508PRO, ABP-
1506, ABP-1306, ABP-
1306 PRO, M1, M3,
M8, M5, M6, K1, K2,
K3, K5, ABP-
1306PLUS, ABP-1308,
M2)
K241004
Subject Device | Electric Breast Pump
K230102
Predicate Device | Comparison |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | HGX | HGX | Same |
| Regulation Number | 21 CFR 884.5160 | 21 CFR 884.5160 | Same |
| Regulatory Class | Class II | Class II | Same |
| Patient Population | Lactating Women | Lactating Women | Same |
| Indications for Use | Wearable Breast Pump (ABP-
1508PRO, ABP-1506, ABP-
1306, ABP-1306 PRO, M1, M3,
M8, M5, M6, K1, K2, K3, K5,
ABP-1306PLUS, ABP-1308,
M2) is a powered breast pump to
be used by lactating women to
express and collect milk from
their breasts. The device is
intended for a single user. | Wearable Breast Pump is a
powered breast pump to be used
by lactating women to express
and collect milk from their
breasts. The device is intended
for a single user. | Same |
| Single/double pump | Single or double | Single | Different |
| Media separation
(backflow
protection) | Yes | Yes | Same |

6

Cycling control mechanismMicrocontrollerMicrocontrollerSame
Expression pattern2-Phase2-PhaseSame
Power supplyLi-Ion Battery and mains poweredLi-Ion Battery and mains poweredSame
Suction levels (stimulation)Single Pumping:
$80-200 \pm 5$ mmHg
Double Pumping:
$60-180 \pm 5$ mmHg$80-200 \pm 5$ mmHgDifferent
Suction levels (expression)Single Pumping:
$90-240 \pm 5$ mmHg
Double Pumping:
$70-220 \pm 5$ mmHg$90-240 \pm 5$ mmHgDifferent
Cycles per minute (stimulation)$64-108 \pm 2$ cycle/min$64-108 \pm 2$ cycle/minSame
Cycles per minute (expression)$26-48 \pm 2$ cycle/min$26-48 \pm 2$ cycle/minSame
Available modes3 modes (stimulation/expression/auto)2 modes (stimulation/expression)Different
Suction levelsAll models: 9 Levels each modeBoth models: 9 Levels each modeSimilar
User InterfaceOn-Off buttons/switches, vacuum adjustment, mode changeOn-Off switch, vacuum adjustment, mode changeSimilar
Adjustable Suction LevelsYesYesSame
Mobile ApplicationNoNoSame
DesignWearable (ABP-1508 PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M2, M3, M8, M5, M6, K1, K2, K3, K5)
Tabletop (ABP-1308, ABP-1306 Plus)Wearable (ABP-1508)Different

The indications for use of the subject and predicate device are identical and they have the same intended use - the expression and collection of breast milk.

The subject and predicate devices have similar technological features, including available number of available vacuum levels, single/double pumping operation, and cycle specifications. However, as shown in the table above, there are technological differences between the subject and predicate device, including different overall vacuum pressure specifications, available pumping modes, tabletop/wearable design, etc. However, the different technological characteristics of the subject device, as compared to the predicate device, do not raise different questions of safety and effectiveness.

9. Summary of Non-Clinical Performance Testing

Biocompatibility

Biocompatibility information was provided in accordance with Attachment G of the 2023 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process."

7

Electrical Safety

Testing was conducted in accordance with IEC 60601- 1 Edition 3.2 2020-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). IEC 6213-2:2017. Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems, and IEC 60601-1-11 Edition 3.1 2020-07 Medical electrical equipment - Part 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.

Electromagnetic Compatibility

Testing was conducted in accordance with IEC 60601-1-2:2014+A1: 2020 Medical Electrical Equipment -Part 1-2: "General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests."

Software

Software was evaluated at the Basic Documentation level as recommended in the 2023 FDA guidance document "Content of Premarket Submissions for Device Software Functions."

Performance Testing

Other performance testing was conducted to show that the device meets its design requirements and performs as intended. The performance tests include:

  • . Vacuum level verification testing at each mode/cycle demonstrated that the devices meet mode/cycle specifications.
  • Backflow protection testing was conducted to verify liquid does not backflow into the tubing.
  • Use life testing was conducted to demonstrate that the device maintains its specifications ● throughout its proposed use life.
  • Battery performance testing was conducted to demonstrate that the battery remains functional ● during its stated battery use-life.
  • Battery status indicator testing was conducted to demonstrate that the battery status indicator ● remains functional during its stated battery life.

10. Conclusion

The results of the performance testing described above demonstrate that the Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) is as safe and effective as the predicate device and supports a determination of substantial equivalence.