The B&I MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

The device can be used in the home or clinical settings to:

Aid in the prevention of DVT;
Enhance blood circulation;
Diminish post-operative pain and swelling;
Reduce wound healing time;
Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs;
As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Device Description

The B&J MHP800 Deep Vein Thrombosis Prevention System is an intermittent pneumatic compression system that aids in the prevention of deep vein thrombosis a potentially life-threatening condition which can lead to pulmonary embolism. The DVT compression device is a non-invasive mechanical prophylactic system that helps decrease the incidence of deep vein thrombosis. The system consists of a pair of pump and sleeve assemblies.

The DVT pump will inflate each leq cuff to a preset pressure of 45mmhg for 12 seconds, and followed by 48 seconds of deflation period once the pressure is reached. This happens once every minute. The cycles are repeated on each unit until the power is turned off.

Internal rechargeable batteries allow the MHP800 to be completely portable to prevent interruptions in treatment.

AI/ML Overview

This document is a 510(k) submission for the B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance data in a format suitable for the requested table.

The provided text does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance numbers, sample sizes, or ground truth establishment methods as typically found in clinical trials or performance assessments for AI/diagnostic devices.

However, I can extract information related to general performance validation and the types of tests conducted.

Here's a breakdown of what can be inferred and what is missing based on your request:

1. Table of acceptance criteria and the reported device performance:

The document states: "All the test results demonstrate MHP800 DVD [DVT] compression device meet the requirements of its predefined acceptance criteria and intended use." (Page 8)
However, the specific numerical acceptance criteria were not explicitly defined, nor were the reported device performance values presented in a comparative table. The document lists categories of tests performed.

Acceptance Criteria Category	Reported Device Performance
Pressure accuracy	"meet the requirements of its predefined acceptance criteria" (specific values not provided in this document)
Cycle time	"meet the requirements of its predefined acceptance criteria" (specific values not provided in this document)
Bladder burst	"meet the requirements of its predefined acceptance criteria" (specific values not provided in this document)
Leak	"meet the requirements of its predefined acceptance criteria" (specific values not provided in this document)
Biocompatibility	Tests conducted, presumed to meet criteria (specific values not provided)
Software validation	Tests conducted, presumed to meet criteria (specific values not provided)
Electromagnetic compatibility and electrical safety	Tests conducted, presumed to meet criteria (specific values not provided)
Reliability	Tests conducted, presumed to meet criteria (specific values not provided)
System level software	Tests conducted, presumed to meet criteria (specific values not provided)

Missing: Specific numerical values for the acceptance criteria and the device's measured performance in these non-clinical tests.

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. The document refers to "non-clinical testing" (Page 8) but does not detail the number of units or test cycles performed for each test.
Data provenance: Not specified. These are non-clinical engineering/performance tests, not human data. The tests were presumably conducted by B&J Manufacturing Ltd. Given the company's address in Shenzhen, China (Page 3), the tests were likely performed there.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. These are non-clinical mechanical/electrical performance tests for a DVT compression device, not a diagnostic device requiring expert interpretation of results for ground truth.

4. Adjudication method for the test set:

Not applicable. This is for non-clinical performance testing.

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 DVT prevention system, not an AI-powered diagnostic tool requiring human interpretation.

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

Not applicable. This device is a DVT prevention system, a mechanical compression device, and does not have a standalone "algorithm-only" performance in the context of AI/diagnostic tools. The performance tests mentioned (pressure accuracy, cycle time, etc.) are inherent to its mechanical function.

7. The type of ground truth used:

Not applicable in the typical sense of expert consensus or pathology for diagnostic devices. For the non-clinical tests listed (pressure accuracy, cycle time, bladder burst, leak), the "ground truth" would be the engineering specifications and established test methodologies (e.g., measuring pressure against a calibrated standard, timing cycles, applying defined force for burst tests).

8. The sample size for the training set:

Not applicable. This is a physical medical device (DVT compression system), not an AI algorithm that requires a training set.

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

Not applicable. (See #8)

Summary of what is present in the document regarding validation:

The document lists "Non-clinical Testing" performed to assess the MHP800 DVT compression device, including:

Biocompatibility
Software validation
Electromagnetic compatibility and electrical safety
Reliability
Performance (System level software, Pressure accuracy, Cycle time, Bladder burst, Leak)

The claim is that "All the test results demonstrate MHP800 DVD compression device meet the requirements of its predefined acceptance criteria and intended use." (Page 8) However, the details of these "predefined acceptance criteria" and the "test results" (i.e., the specific performance numbers achieved) are not disclosed in this document. The purpose of this 510(k) summary is to assert substantial equivalence, not to provide a detailed study report.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 10, 2020

B & J Manufacturing Ltd % Fu Ailing Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1713A, 17F, Black A, Time Square, Xili Town Shenzhen, Guangdong 518055 China

Re: K200568

Trade/Device Name: B&J MHP800 Deep Vein Thrombosis Prevention System Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: May 5, 2020 Received: June 8, 2020

Dear Fu Ailing:

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. 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 located 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 Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-reportingmdr-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 (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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,

for Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support. Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K200568

Device Name

B&J MHP800 Deep Vein Thrombosis Prevention System

Indications for Use (Describe)

The device can be used in the home or clinical settings to:

Aid in the prevention of DVT;
Enhance blood circulation;
Diminish post-operative pain and swelling;
Reduce wound healing time;
Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs;
As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

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)
--------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | 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) Submission

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR807.92 (a) (1)]

February 10, 2020

2. Submitter's Information [21 CFR807.92 (a) (1)]

Name of Sponsor: B&J Manufacturing Ltd.

Address: Room 701 & 101, Building 24, Block B, Yuanshan Industrial Zone, Shangcun Community, Gongming Street, Guangming District, Shenzhen, 518106 China

Contact Name: Billy Yu

Telephone No.: +86-0755-88210239

Fax No.: +86-0755-88210289

Email Address: yl_billy@126.com

3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]

Trade Name/Model:	B&J MHP800 Deep Vein Thrombosis Prevention System
Common Name:	MHP800 DVT Compression Device
Classification Name:	Sleeve, Limb, Compressible
Regulation Number:	21 CFR 870.5800
Product code:	JOW
Classification Panel:	Cardiovascular
Device Class:	II

4. Identification of Predicate and Reference Devices [21 CFR 807.92(a) (3)]

The identified predicate within this submission is as follows: Devon Medical Products, Cirona 6300 Disposable Deep Vein Thrombosis (DVT)

{4}------------------------------------------------

Prevention System has been cleared by FDA through 510(k) No. K151189 (Decision Date - September 18, 2015).

The identified reference devices within this submission are as follows: Eezcare Medical Corp, Ezvena IPC, Ezvena SQS has been cleared by FDA through 510(k) No. K191937 (Decision Date - January 29, 2020). Devon Medical Inc., Cirona 6200 Deep Vein Thrombosis Prevention System has been cleared by FDA through 510(k) No. K141578 (Decision Date - June 27, 2014).

5. Description of the Device [21 CFR 807.92(a) (4)]

Internal rechargeable batteries allow the MHP800 to be completely portable to prevent interruptions in treatment.

6. Intended Use [21 CFR 807.92(a)(5)]

The B&J MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).

The device can be used in the home or clinical settings to:

Aid in the prevention of DVT;
Enhance blood circulation;
Diminish post-operative pain and swelling;
Reduce wound healing time;
Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs;

{5}------------------------------------------------

As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

7. Technological Characteristics [21 CFR 807.92(a)(6)]

General Specification:
Model No.	MHP800
Size	145mm (L)61mm(W)36mm(H)
Weight	0.2 kg
AC/DC Adapter	AC Input: 100V-240V 50/60Hz; DC Output: 5V, 2A (2 plugs)
Mode of Operation/ Operating Time	Continuous / 8 hours
Battery Type	Lithium Battery 7.4V 650mAh (rechargeable)
Charging Time	2.5 Hours
Pressure Range	45 ±10% mmHg (default)
Reset Time	60s
Humidity	Operation: 15% to 93 % (without condensation)Storage & Transportation: 10% to 95% (without condensation)
Air pressure	Operation: 525mmHg to 795mmHgStorage & Transportation: 165mmHg-805mmHg
Temperature	Operation: +5° C (41° F) to +40° C (104° F)Storage & Transportation: -20° C (-4° F) to +55° C (131° F)
Sleeve component:
Model Name	Description	Circumference
MHP801M	MediumLatex Free Calf Garment (Pair)	Up to 18"

MHP800 DVT Pump

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

8.1 Intended use:

{6}------------------------------------------------

ID	Comparison Item	Proposed DeviceB&J DVT Prevention System(MHP800)	Predicate DeviceDevon DVT Prevention System(Cirona 6300)
1	510(K) No.	To be assigned	K151189
2	Intended Use	The B&J MHP800 deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).The device can be used in the home or clinical settings to:- Aid in the prevention of DVT;- Enhance blood circulation;- Diminish post-operative pain and swelling;- Reduce wound healing time;- Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs;- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time	The Cirona 6300 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions).The device can be used in the home or clinical settings to:· Aid in the prevention of DVT;· Enhance blood circulation;· Diminish post-operative pain and swelling;· Reduce wound healing time;· Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs;· As a prophylaxis for DVT by persons expecting to be stationary for long periods of time
3	Type of use	Prescription Use	Prescription Use
ID	Comparison Item	Proposed DeviceB&J DVTPreventionSystem(MHP800)	Predicate DeviceDevon DVTPreventionSystem(Cirona 6300)	Explanation of Difference
4	General Specification
4.1	Size	145 6136(mm)	65 13030(mm)	Different butdoes not raiseany new issueof substantialequivalence
4.2	Weight	0.2 kg	0.3 kg	Different butdoes not raiseany new issueof substantialequivalence
4.3	AC/DC Adapter	AC Input:100V-240V50/60Hz; DC Output:5V, 2A (2 plugs)	AC Input:100V-240V50/60Hz; DC Output:5V, 2A (2 plugs)
4.4	Mode ofOperation/Operating Time	Continuous / 8hours	Continuous / 8hours
4.5	Battery Type	Lithium Battery7.4V 650mAh(rechargeable)	Lithium Battery3.7V 1350mAh(rechargeable)	Different butdoes not raiseany new issueof substantialequivalence;Refer toK151189 andK170814.
4.6	Charging Time	2.5 Hours	3 Hours	Different butdoes not raiseany new issueof substantialequivalence;Refer toK151189 andK170814.

4.7	Pressure Range	$45\pm10%$ mmHg(default)	$50\pm5$ mmHg(default)	Different butdoes not raiseany new issueof substantialequivalence;Refer toK191937.
4.8	Reset Time	60s	50s	Different butdoes not raiseany new issueof substantialequivalence;Refer toK141578.
4.9	Applied Mode ofPressure	Intermittent	Intermittent	-

Table 1 Intended Use Comparison

8.2 Comparison table

{7}------------------------------------------------

Table 2 General Comparison between MHP800 and Cirona 6300

{8}------------------------------------------------

It is clear that MHP800 is as safe and effective as the predicate by comparing above technological characteristics.

8.3 Non-clinical Testing

The following safety and performance tests were conducted to assess MHP800 DVT compression device.

0 Biocompatibility
0 Software validation
O Electromagnetic compatibility and electrical safety
0 Reliability
0 Performance
- System level software
- Pressure accuracy
- Cycle time
- Bladder burst
- Leak

All the test results demonstrate MHP800 DVD compression device meet the requirements of its predefined acceptance criteria and intended use.

{9}------------------------------------------------

9. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, B&J Manufacturing Ltd. concludes that:

The intended use of MHP800 is totally same as that of the predicate device.
The technological characteristics differences between MHP800 and Cirona 6300 do not affect the safety and effectiveness, no new risk is raised.
Demonstrated by the safety and performance tests, the characteristics of MHP800 is equivalent to those of the predicate device.

Regulation Number and Section

§ 870.5800 Compressible limb sleeve.

(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *

510(k) Summary

1. Date Prepared [21 CFR807.92 (a) (1)]

2. Submitter's Information [21 CFR807.92 (a) (1)]

3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]

4. Identification of Predicate and Reference Devices [21 CFR 807.92(a) (3)]

5. Description of the Device [21 CFR 807.92(a) (4)]

6. Intended Use [21 CFR 807.92(a)(5)]

7. Technological Characteristics [21 CFR 807.92(a)(6)]

MHP800 DVT Pump

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

8.1 Intended use:

Table 1 Intended Use Comparison

8.2 Comparison table

Table 2 General Comparison between MHP800 and Cirona 6300

8.3 Non-clinical Testing

9. Conclusion [21 CFR 807.92(b) (3)]

§ 870.5800 Compressible limb sleeve.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW