(128 days)
No
The device description details a simple, fixed-cycle intermittent pneumatic compression system with no mention of adaptive algorithms, learning, or AI/ML terms.
Yes.
The device is intended to prevent deep vein thrombosis and aid in the treatment of various conditions, including stasis dermatitis, venous stasis ulcers, and chronic venous insufficiency, which are therapeutic applications.
No
Explanation: The device is described as a "prevention system" that stimulates blood flow and helps prevent DVT. It does not mention diagnosing any conditions.
No
The device description explicitly states it consists of "a pair of pump and sleeve assemblies" and "Internal rechargeable batteries," indicating it is a hardware device with software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The B&I MHP800 is an intermittent pneumatic compression system that physically stimulates blood flow in the extremities. It works externally on the body and does not analyze any biological samples.
- Intended Use: The intended use is to prevent DVT and aid in the treatment of various circulatory conditions by applying external pressure. This is a therapeutic and preventative function, not a diagnostic one based on analyzing biological samples.
Therefore, the B&I MHP800 is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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
Product codes
JOW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
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)
The following safety and performance tests were conducted to assess MHP800 DVT compression device.
- Biocompatibility
- Software validation
- Electromagnetic compatibility and electrical safety
- Reliability
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 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
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)
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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)]
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.
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 795mmHg | |
| Storage & 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 | Medium | |
| Latex 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 Device
B&J DVT Prevention System
(MHP800) | Predicate Device
Devon 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 Device
B&J DVT
Prevention
System
(MHP800) | Predicate Device
Devon DVT
Prevention
System
(Cirona 6300) | Explanation of Difference |
| 4 | General Specification | | | |
| 4.1 | Size | 145 6136(mm) | 65 13030(mm) | Different but
does not raise
any new issue
of substantial
equivalence |
| 4.2 | Weight | 0.2 kg | 0.3 kg | Different but
does not raise
any new issue
of substantial
equivalence |
| 4.3 | AC/DC Adapter | AC Input:
100V-240V
50/60Hz; DC Output:
5V, 2A (2 plugs) | AC Input:
100V-240V
50/60Hz; DC Output:
5V, 2A (2 plugs) | |
| 4.4 | Mode of
Operation/
Operating Time | Continuous / 8
hours | Continuous / 8
hours | |
| 4.5 | Battery Type | Lithium Battery
7.4V 650mAh
(rechargeable) | Lithium Battery
3.7V 1350mAh
(rechargeable) | Different but
does not raise
any new issue
of substantial
equivalence;
Refer to
K151189 and
K170814. |
| 4.6 | Charging Time | 2.5 Hours | 3 Hours | Different but
does not raise
any new issue
of substantial
equivalence;
Refer to
K151189 and
K170814. |
| | | | | |
| 4.7 | Pressure Range | $45\pm10%$ mmHg
(default) | $50\pm5$ mmHg
(default) | Different but
does not raise
any new issue
of substantial
equivalence;
Refer to
K191937. |
| 4.8 | Reset Time | 60s | 50s | Different but
does not raise
any new issue
of substantial
equivalence;
Refer to
K141578. |
| 4.9 | Applied Mode of
Pressure | 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.