(168 days)
No
The device description details a purely mechanical and pneumatic system operating on preset timing cycles and pressures. There is no mention of adaptive learning, pattern recognition, or any other characteristic typically associated with AI/ML. The performance studies focus on standard engineering and safety tests, not AI/ML model validation.
Yes
The device is intended to prevent deep vein thrombosis and increase venous blood flow, which are therapeutic actions.
No
The device is a therapeutic device designed to prevent deep vein thrombosis by increasing venous blood flow, not to diagnose a condition.
No
The device description explicitly states it consists of an air pump and compression garments, which are hardware components. The device functions by delivering compressed air to these garments.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis." This is a therapeutic and preventative action performed directly on the patient's body.
- Device Description: The device is described as an "external pneumatic compression (EPC) device" that applies pressure to the extremities. This is a physical intervention, not a test performed on biological samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on laboratory tests
- Using reagents or assays
The device functions by applying external pressure to the body to improve blood flow, which is a mechanical and physical intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The B&J Manufacturing Ltd. MHH800 and MHH800SQ Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
Product codes
JOW
Device Description
The Deep Vein Thrombosis (DVT) Pumps MHH800 and MHH800SQ are external pneumatic compression (EPC) devices that aid in the prevention of DVT from a potentially life threatening condition which can lead to pulmonary embolism. MHH800 and MHH800SQ are non-invasive mechanical prophylactic devices. The devices function as secondary pumps to propel venous blood for patients whose deep veins thrombosis must be prevented after surgeries in Orthopaedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.
Model variations are distinguished by characters. MHH800 is without SQ, so the device means an intermittent pneumatic compression pump. MHH800SQ is with SQ, so the device means a sequential pneumatic compression pump.
The two devices separately consist of an air pump and a soft pliable compression garment(s) for the foot, calf or thigh. For MHH800, the controller supplies compression on a preset timing cycle (12 seconds inflation and maintenance followed by 48 seconds of deflation) at a suggested pressure setting of 40 mmHg for the Leg and 120mmHg for the Foot. For MHH800SQ, the controller supplies compression on a preset timing cycle (12 seconds inflation followed by 48 seconds of deflation) at a suggested pressure setting, 45mmHg in the 1st chamber, 40 mmHg in the 2nd chamber and 30mmHg in the 3rd chamber for the Leg and 120mmHg for the Foot. The pressure in the garments is transferred to the extremity, augmenting venous blood flow when the leg is compressed, reducing stasis. This process also stimulates fibrinolysis; thus, reducing the risk of early clot formation.
The DVT pumps produce automatically timed cycles of compressed air. This compressed air forces blood out of the deep veins, helping to prevent slowed or stopped blood flow. Bursts of air are delivered to the specially designed garments wrapped around extremities. This air helps to move blood out of the deep veins and reduce the risk of developing DVT. Garments are lined with tricot fabric to help reduce heat and perspiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
leg, foot, calf, thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 MHH800 and MHH800SQ DVT compression devices.
- Biocompatibility
- Software validation
- Electromagnetic compatibility and electrical safety
- Reliability
- Performance
- System level software
- Pressure accuracy
- Cycle time
- Bladder burst
All the test results demonstrate MHH800 and MHH800SQ DVD compression devices meet the requirements of their predefined acceptance criteria and intended uses.
No clinical testing was used to support the decision of safety and effectiveness.
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 shows 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 the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 8, 2020
B & J Manufacturing Ltd. % Fu Ailing Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1713A, 17F, Block A, Time Square, Xili Town Shenzhen, 518055 Cn
Re: K200154
Trade/Device Name: B&J DVT Compression Devices MHH800/MHH800SQ Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 28, 2019 Received: January 22, 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.
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
1
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 (OS) 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 mediation-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)
Device Name B&J DVT Compression Devices MHH800/MHH800SQ
Indications for Use (Describe)
The B&J Manufacturing Ltd. MHH800 and MHH800SQ Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
3
510(k) Submission
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR807.92 (a) (1)]
December 28, 2019
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 DVT Compression Devices MHH800/MHH800SQ
Common Name: MHH800/MHH800SQ DVT Pumps
Classification Name: Sleeve, Limb, Compressible
Regulation Number: 21 CFR 870.5800
Product code: JOW
Classification Panel: Cardiovascular
Device Class: Il
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicates within this submission are as follows: Caremed Supply, Inc., VESOFLOW PLUS DVT Compression Devices, IPCS/SQS have been cleared by FDA through 510(k) No. K141064 (Decision Date - December 4, 2014).
4
5. Description of the Device [21 CFR 807.92(a) (4)]
The Deep Vein Thrombosis (DVT) Pumps MHH800 and MHH800SQ are external pneumatic compression (EPC) devices that aid in the prevention of DVT from a potentially life threatening condition which can lead to pulmonary embolism. MHH800 and MHH800SQ are non-invasive mechanical prophylactic devices. The devices function as secondary pumps to propel venous blood for patients whose deep veins thrombosis must be prevented after surgeries in Orthopaedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.
Model variations are distinguished by characters. MHH800 is without SQ, so the device means an intermittent pneumatic compression pump. MHH800SQ is with SQ, so the device means a sequential pneumatic compression pump.
The two devices separately consist of an air pump and a soft pliable compression garment(s) for the foot, calf or thigh. For MHH800, the controller supplies compression on a preset timing cycle (12 seconds inflation and maintenance followed by 48 seconds of deflation) at a suggested pressure setting of 40 mmHg for the Leg and 120mmHg for the Foot. For MHH800SQ, the controller supplies compression on a preset timing cycle (12 seconds inflation followed by 48 seconds of deflation) at a suggested pressure setting, 45mmHg in the 1st chamber, 40 mmHg in the 2nd chamber and 30mmHg in the 3rd chamber for the Leg and 120mmHg for the Foot. The pressure in the garments is transferred to the extremity, augmenting venous blood flow when the leg is compressed, reducing stasis. This process also stimulates fibrinolysis; thus, reducing the risk of early clot formation.
The DVT pumps produce automatically timed cycles of compressed air. This compressed air forces blood out of the deep veins, helping to prevent slowed or stopped blood flow. Bursts of air are delivered to the specially designed garments wrapped around extremities. This air helps to move blood out of the deep veins and reduce the risk of developing DVT. Garments are lined with tricot fabric to help reduce heat and perspiration.
6. Intended Use [21 CFR 807.92(a)(5)]
The B&J Manufacturing Ltd. MHH800 and MHH800SQ Deep Vein Thrombosis (DVT) Compression Devices are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.
5
7. Technological Characteristics [21 CFR 807.92(a)(6)]
| General Specification: | |||
|---|---|---|---|
| Model No. | MHH800 | ||
| Size | 6.5" (L) x 7.0" (W) x 12.8" (H) | ||
| Weight | 2.1 kg | ||
| Pressure Range | Calf/Thigh Garment: 40mmHg +10/-5mmHg | ||
| Foot Garment: 120mmHg +10/-5mmHg | |||
| Input Rating | AC 100V-240V 50/60Hz 1A | ||
| Fuse Rating | 1A or T1AH 250V | ||
| Classification | Class I Type BF | ||
| Not AP or AGP type 🚶 | |||
| Humidity | Operation: 30% to 75 % | ||
| Storage & Transportation: 30% to 75% | |||
| Air pressure | 75 - 106KPA | ||
| Temperature | Operation: 15°- 35° C | ||
| Storage & Transportation: 5 - 60° C | |||
| Cycle Time | Inflation 12 seconds +/- 10% | ||
| Deflation 48 seconds +/- 10% | |||
| Applied Part | Garments and Air Tube (100% latex free) | ||
| Battery | Battery pack: 4 x series Li-ion battery cell | ||
| Battery pack capacity: 2800mAh (Nominal), | |||
| 2750mAh (minimum) | |||
| Nominal voltage: 14.8V | |||
| Temperature: Operation 15° ~ 35°C Storage 5° ~ 60°C | |||
| Garment for the DVT Pump: | |||
| Model Name | Description | Circumference | |
| MHH801P | Pediatric Latex Free Calf Garment (Pair) | Up to 14" | |
| MHH801M | Medium Latex Free Calf Garment (Pair) | Up to 18" | |
| MHH801L | Large Latex Free Calf Garment (Pair) | Up to 24" | |
| MHH801B | Extra Large Latex Free Calf Garment (Pair) | Up to 32" | |
| MHH820M | Medium Latex Free Foot Garment (Pair) | Up to 13" | |
| MHH820L | Large Latex Free Foot Garment (Pair) | Up to 16" | |
| MHH830S | Small Latex Free Thigh Garment (Pair) | Up to 22" | |
| MHH830M | Medium Latex Free Thigh Garment (Pair) | Up to 29" | |
| MHH830L | Large Latex Free Thigh Garment (Pair) | Up to 36" | |
| MHH830B | Extra Large Latex Free Thigh Garment (Pair) | Up to 42" | |
| Air Hose Extension for the DVT Pump: | |||
| 810 | Air hose extension of 59" (Pair) | ||
| 810L | Air hose extension of 59" (Pair) |
MHH800 DVT Pump
6
MHH800SQ DVT Pump
| General Specification: | |||
|---|---|---|---|
| Model No. | MHH800SQ | ||
| Size | 6.5" (L) x 7.0" (W) x 12.8" (H) | ||
| Weight | 2.58 kg | ||
| Pressure Range | Calf/Thigh Garment: 45/40/30mmHg +10/-5mmHg | ||
| Foot Garment: 120mmHg +10/-5mmHg | |||
| Input Rating | AC 100V-240V 50/60Hz | ||
| Fuse Rating | 1A or T1AH 250V | ||
| Classification | Class I Type BF | ||
| Image: [man in wheelchair symbol] | |||
| Not AP or AGP type | |||
| Humidity | Operation: 30% to 75 % | ||
| Storage & Transportation: 30% to 75% | |||
| Air pressure | 75 - 106KPA | ||
| Temperature | Operation: 15°- 35° C | ||
| Storage & Transportation: 5 - 60° C | |||
| Cycle Time | Inflation 12 seconds +/- 10% | ||
| Deflation 48 seconds +/- 10% | |||
| Applied Part | Garments and Air Tube (100% latex free) | ||
| Battery | Battery pack: 4 x series Li-ion battery cell | ||
| Battery pack capacity: 2800mAh (Nominal), 2750mAh (minimum) | |||
| Nominal voltage: 14.4V | |||
| Temperature: Operation 15° ~ 35°C Storage 5° ~ 60°C | |||
| Garment for the DVT Pump: | |||
| Model Name | Description | Circumference | |
| MHH801SSQ | Small | Latex Free Calf Garment (Pair) | Up to 14" |
| MHH801MSQ | Medium | Latex Free Calf Garment (Pair) | Up to 18" |
| MHH801LSQ | Large | Latex Free Calf Garment (Pair) | Up to 24" |
| MHH801BSQ | Extra Large | Latex Free Calf Garment (Pair) | Up to 32" |
| MHH820MSQ | Medium | Latex Free Foot Garment (Pair) | Up to 13" |
| MHH820LSQ | Large | Latex Free Foot Garment (Pair) | Up to 16" |
| MHH830SSQ | Small | Latex Free Thigh Garment (Pair) | Up to 22" |
| MHH830MSQ | Medium | Latex Free Thigh Garment (Pair) | Up to 29" |
| MHH830LSQ | Large | Latex Free Thigh Garment (Pair) | Up to 36" |
| MHH830BSQ | Extra Large | Latex Free Thigh Garment (Pair) | Up to 42" |
| Air Hose Extension for the DVT Pump: | |||
| 810SQ | Air hose extension of 59" (Pair) | ||
| 810LSO | Air hose extension of 59" (Pair) |
7
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
8.1 Intended uses:
| ID | Comparison
Item | Proposed Device
B&J DVT Compression
Devices
(MHH800/MHH800SQ) | Predicate Device
VESOFLOW PLUS DVT
Compression Devices
(IPCS/SQS) |
|----|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510(K) No. | K200154 | K141064 |
| 2 | Intended
Use | The B&J Manufacturing Ltd.
MHH800 and MHH800SQ
Deep Vein Thrombosis (DVT)
Compression Devices are
intended to increase venous
blood flow in at risk patients in
order to help prevent deep
vein thrombosis. | The Caremed Supply Inc.
VESOFLOW® PLUS SQS and
IPCS Deep Vein Thrombosis
(DVT) Compression Devices
are intended to increase
venous blood flow in at risk
patients in order to help
prevent deep vein thrombosis. |
| 3 | Type of use | Prescription Use | Prescription Use |
| 4 | Single use? | Reusable(note) | Single use |
Table 1 Intended Use Comparison
Note:
The proposed devices can be reusable since their cleaning and disinfection have been validated according to Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff at https://www.fda.gov/media/80265/download and Labeling and Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 at https://www.cdc.gov/infectioncontrol/ guidelines/disinfection/.
8
8.2 Comparison table
| Table 2 General Comparison between MHH800 and VESOFLOW®PLUS IPCS |
|---|
| ------------------------------------------------------------------- |
| ID | Comparison
Item | Proposed Device
B&J DVT
Compression
Device (MHH800) | Predicate Device
VESOFLOW PLUS
DVT Compression
Device
(IPCS) | Explanation
of Difference |
|------|-----------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| 4 | | General Specification | | |
| 4.1 | Size | 6.5"x7.0"x12.8" | 7.54"x5.12"x7.95" | Different but
does not raise
any new issue
of substantial
equivalence |
| 4.2 | Weight | 2.1kg | 2.8kg | Different but
does not raise
any new issue
of substantial
equivalence |
| 4.3 | Pressure Range | Calf/Thigh:40;
Foot:120 | Calf/Thigh:40;
Foot:130 | Different but
same as
Reference
Device
K061814(Calf/
Thigh:40;
Foot: 80-120)
or
K181217(Calf/
Thigh:40;
Foot:120) |
| 4.4 | Input Rating | AC 100-240V,
50/60Hz | AC 100-240V,
50/60Hz | |
| 4.5 | Fuse Rating | 1A or T1AH 250V | 1A/250V | |
| 4.6 | Classification | Class I Type BF
Not AP or AGP type
Image: walking person symbol | Class I Type BF
Not AP or AGP type
Image: walking person symbol | |
| 4.7 | Operation
Humidity | 30-75% | 30-75% | |
| | | | | |
| 4.8 | Storage &
Transportation
Humidity | 30-75% | 30-75% | - |
| 4.9 | Operation
Temperature | 15°C-35°C | 15°C-35°C | - |
| 4.10 | Storage &
Transportation
Temperature | 5°C-60°C | 5°C-60°C | - |
| 4.11 | Applied Part | Garment and Air
Hose | Garment and Air
Hose | - |
| 4.12 | Applied Mode of
Pressure | Intermittent | Intermittent | - |
| 4.13 | Number of
Chambers in
Garment | No | No | - |
| 4.14 | Inflation time per
chamber
(Calf/Thigh) | 12 seconds | 12 seconds | - |
| 4.15 | Deflation time per
chamber
(Calf/Thigh) | 48 seconds | 48 seconds | - |
| 4.16 | Inflation time per
chamber (Foot) | 12 seconds | 3 seconds | Different but
same as
Reference
Device
K061814 or
K181217 (all
12 seconds) |
| 4.17 | Deflation time per
chamber (Foot) | 48 seconds | 30 seconds | Different but
same as
Reference
Device
K061814 or
K181217 (all
48 seconds) |
| 4.18 | Pressure Range
Calf/Thigh | 40mmHg | 40mmHg | - |
| 4.19 | Pressure Range
Foot | 120mmHg | 130mmHg | Different but
same as
Reference
Device
K061814
(Foot: 80-120)
or K181217
(Foot: 120) |
| 4.20 | Pre-Programmed
Controls | Yes | Yes | - |
| 4.21 | Battery Pack | Yes | Yes | - |
| 4.22 | Garments | 100% latex free | 100% latex free | - |
9
10
Table 3 General Comparison between MHH800SQ and VESOFLOW®PLUS SQS
| ID | Comparison
Item | Proposed Device
B&J DVT
Compression
Device
(MHH800SQ) | Predicate Device
VESOFLOW PLUS
DVT Compression
Device
(SQS) | Explanation
of Difference |
|------|--------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| 5 | | General Specification | | |
| 5.1 | Size | 6.5"x7.0"x12.8" | 7.54"x5.12"x7.95" | Different but
does not raise
any new issue
of substantial
equivalence |
| 5.2 | Weight | 2.58kg | 2.8kg | Different but
does not raise
any new issue
of substantial
equivalence |
| 5.3 | Pressure Range | Calf/Thigh: 45, 40
and 30mmHg
Foot: 120mmHg | Calf/Thigh: 45, 40
and 30mmHg
Foot: 130mmHg | Different but
same as
Reference
Device
K061814
(Foot: 80-120)
or K181217
(Foot: 120)) |
| 5.4 | Input Rating | AC 100-240V, 50/60Hz | AC 100-240V, 50/60Hz | - |
| 5.5 | Fuse Rating | 1A or T1AH 250V | 1A/250V | - |
| 5.6 | Classification | Class I Type BF Not AP or AGP type
Image: Man in wheelchair | Class I Type BF Not AP or AGP type
Image: Man in wheelchair | - |
| 5.7 | Operation Humidity | 30-75% | 30-75% | - |
| 5.8 | Storage & Transportation Humidity | 30-75% | 30-75% | - |
| 5.9 | Operation Temperature | 15°C-35°C | 15°C-35°C | - |
| 5.10 | Storage & Transportation Temperature | 5°C-60°C | 5°C-60°C | - |
| 5.11 | Applied Part | Garment and Air Hose | Garment and Air Hose | - |
| 5.12 | Applied Mode of Pressure | Sequential | Sequential | - |
| 5.13 | Number of Chambers in Garment | 3 | 3 | - |
| 5.14 | Inflation time per chamber | 12 seconds | 12 seconds | - |
| 5.15 | Deflation time per chamber | 48 seconds | 48 seconds | - |
| 5.16 | Pressure sequence calf/thigh | 45, 40 and 30 mmHg | 45, 40 and 30 mmHg | - |
| 5.17 | Pressure range calf/thigh | 45, 40 and 30 mmHg | 45, 40 and 30 mmHg | - |
| 5.18 | Pressure Range
Foot | 120mmHg | 130mmHg | Different but
same as
Reference
Device
K061814
(Foot: 80-120)
or K181217
(Foot: 120) |
| 5.19 | Pre-Programmed
Controls | Yes | Yes | - |
| 5.20 | Battery Pack | Yes | Yes | - |
| 5.21 | Garments | 100% latex free | 100% latex free | - |
11
12
It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MHH800 and MHH800SQ.
8.3 Non-clinical Testing
The following safety and performance tests were conducted to assess MHH800 and MHH800SQ DVT compression devices.
- Biocompatibility
- 0 Software validation
- O Electromagnetic compatibility and electrical safety
- O Reliability
- O Performance
- System level software
- Pressure accuracy
- Cycle time
- Bladder burst
All the test results demonstrate MHH800 and MHH800SQ DVD compression devices meet the requirements of their predefined acceptance criteria and intended uses.
No clinical testing was used to support the decision of safety and effectiveness.
13
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 MHH800 and MHH800SQ is totally same as that of the predicate devices.
- The technological characteristics differences between MHH800 and IPCS, and between MHH800SQ and SQS do not affect the safety and effectiveness, no new risk is raised.
- Demonstrated by the safety and performance tests, the characteristics of MHH800 and MHH800SQ are equivalent to those of the predicate devices.