Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on a preset timing cycle and pressure settings, with no mention of adaptive or learning capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

Yes
The device is intended to prevent deep vein thrombosis by increasing venous blood flow, which is a therapeutic purpose.

Diagnostic

No

This device is a therapeutic device designed to prevent deep vein thrombosis by increasing venous blood flow, not a diagnostic device used to identify or characterize a disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of an air pump and compression garments, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

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 function 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 a sample taken from the body.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates externally on the patient to influence blood flow.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

MedHealth DVT Compression Devices MHH900S/MHH900E 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 MHH900S and MHH900E 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. MHH900S and MHH900E are non-invasive mechanical prophylactic devices function as secondary pumps to propel venous blood for patients whose deep vein thrombosis must be prevented after surgeries in Orthopedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.

The two devices separately consist of an air pump and a soft pliable compression garment(s) (Purchased separately) for the foot, calf, or thigh. For MHH900S and MHH900E, 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. The pressure in the qarments 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.

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)

Non-clinical testing was conducted to assess MHH900S and MHH900E DVT compression Devices:

A Software validation
Cleaning and Disinfection validation—Testing was performed to, and passed, the following standards:
- AAMI TIR12: 2020 Designing, Testing And Labeling Reusable Medical Devices For Reprocessing In Health Care Facilities: A Guide For Medical Device Manufacturers
- ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices
- AAMI ST98-2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical device
Electromagnetic compatibility and electrical safety-- testing was performed to, and passed, the following standards:
- IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests
- IEC 60601-1-8 Medical electrical equipment –Part 1-8: General requirements for basic safety and essential performance –Collateral standard: General Requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC TR 60601-4-2:2016 Medical electrical equipment –Part 4-2: Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
A Shelf life (aging test)—Follow ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Device
A Performance test summary: Testing was performed and to ensure that the system meets its specifications. The functional performance testing includes the following tests:
- Pressure accuracy Range-Calf/Thigh Garment
- Pressure accuracy Range- Foot Garment
- Cycle Time-Inflation
- Cycle Time-Deflation
- Burst Testing
- Pressure Leakage testing

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)

K200154

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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 the FDA logo, which 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.

December 14, 2023

MedHealth Medical Limited Steven Jiang General Manager 701/101, BLDG 24, Block B, Yuanshan Zone Shangcun, Gongming Shenzhen, Guangdong 518106 China

Re: K231801

Trade/Device Name: MedHealth DVT compression Devices MHH900S/MHH900E Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: June 1, 2023 Received: June 20, 2023

Dear Steven Jiang:

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

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).

1

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 OS 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-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 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.

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-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,

Eric E. Richardson -STDV

for Nicole Gillette 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K231801

Device Name

MedHealth DVT compression Devices MHH900S/MHH900E

Indications for Use (Describe)

MedHealth DVT Compression Devices MHH900S/MHH900E are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

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)

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

MHH900S/MHH900E DVT Compression Devices

510(k) Summary [As required by 21 CFR 807.92]

1. Date Prepared [21 CFR807.92 (a) (1)] Nov 21,2023
1. Submitter's Information [21 CFR807.92 (a) (1)] Name of Sponsor: MedHealth Medical Limited

Address: 701/101, BLDG 24, Block B, Yuanshan Zone, Shangcun, Gongming, Shenzhen, 518106, China Contact Name: Steven Jiang Telephone No.: +86-13502865807 Fax No.: +86-755-88210289 Email Address: steven.jiang@medhealth.com.cn

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

Trade Name/Model: MedHealth DVT compression Devices MHH900S/MHH900E Common Name, MHH900S/MHH900E DVT Pumps Classification Name: Sleeve, Limb, Compressible Regulation Number: 21 CFR 870.5800 Product code: JOW Classification Panel: Cardiovascular Device Class: Class II

4. Identification of predicated Device (S) [21 CFR807.92 (a) (3)]

The predicate device is B&J Manufacturing Ltd. Deep Vein Thrombosis (DVT) compression device MHH800 (K200154)

5. Description of the Device [21 CFR807.92 (a) (4)]

The Deep Vein Thrombosis (DVT) Pumps MHH900S and MHH900E 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. MHH900S and MHH900E are non-invasive mechanical prophylactic devices function as secondary

4

510(k) Submission

pumps to propel venous blood for patients whose deep vein thrombosis must be prevented after surgeries in Orthopedics etc. Additionally, the devices are reusable and can be used for more than one patient within its lifecycle.

The two devices separately consist of an air pump and a soft pliable compression garment(s) (Purchased separately) for the foot, calf, or thigh. For MHH900S and MHH900E, 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. The pressure in the qarments 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.

6. Intended Use [21 CFR807.92 (a) (5)]

MedHealth DVT Compression Devices MHH900S and MHH900E are intended to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis.

5

510(k) Submission

7. Technological Characteristics [21 CFR807.92 (a) (6)]

MHH900S DVT Pump

General Specification:
Model No.	MHH900S
Size	8.6" (L) x 6.2" (W) x 8.98" (H)
Weight	2.48 kg
Pressure Range	Calf/Thigh Garment: 40 mmHg +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 80 %
Storage & Transportation: 30% to 93%
Air pressure	75 - 106KPA
Temperature	Operation: 5° C- 40° C
Storage & Transportation: 5° C - 55° C
Cycle Time	Inflation 12 seconds +/- 1 second
Deflation 48 seconds +/- 2 seconds
Applied Part	Garments (Purchased separately) and Air Tube
Battery	Battery pack: 4 x series Li-ion battery cell
Battery pack capacity: 2900mAh (Nominal),
2700mAh (minimum)
Nominal voltage: 14.4V
Temperature: Operation 5°C ~ 40°C Storage 5°C ~ 55°C
Garment for the DVT Pump (Purchased separately) :
Model Name	Applied Part	Specification
801P	Calf	Small, for calf circumference up to 14" (35 cm)
801M	Calf	Medium, for calf circumference up to 18" (45 cm)
801L	Calf	Large, for calf circumference up to 24" (61 cm)
801B	Calf	Extra Large, for calf circumference up to 32" (81 cm)
820M	Foot	Medium, for foot sizes up to 13"
820L	Foot	Large, for foot sizes up to 16"
830S	Full-Leg	Small, for thigh circumference up to 22" (55 cm)
830M	Full-Leg	Medium, for thigh circumference up to 29" (73 cm)
830L	Full-Leg	Large, for thigh circumference up to 36" (91 cm)
830B	Full-Leg	Extra Large, for thigh circumference up to 42" (106 cm)
Air Hose Extension for the DVT Pump:
810		Air hose extension of 59" (Pair)
810L		Air hose extension of 118" (Pair)

6

510(k) Submission

General Specification:
Model No.	MHH900E
Size	8.6" (L) x 6.2" (W) x 8.98" (H)
Weight	2.48 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
Image: [Person Symbol]
Humidity	Operation: 30% to 80 %
Storage & Transportation: 30% to 93%
Air pressure	75 - 106KPA
Temperature	Operation: 5° C- 40° C
Storage & Transportation: 5° C - 55° C
Cycle Time	Inflation 12 seconds +/- 1 second
Deflation 48 seconds +/- 2 seconds
Applied Part	Garments (Purchased separately) and Air Tub
Battery	Battery pack: 4 x series Li-ion battery cell
Battery pack capacity: 2900mAh (Nominal),
2700mAh (minimum)
Nominal voltage: 14.4V
Temperature: Operation5°C ~ 40°C Storage 5°C ~ 55°C
Garment for the DVT Pump (Purchased separately) :
Model Name	Applied Part Specification
801P	Calf Small, for calf circumference up to 14" (35 cm)
801M	Calf Medium, for calf circumference up to 18" (45 cm)
801L	Calf Large, for calf circumference up to 24" (61 cm)
801B	Calf Extra Large, for calf circumference up to 32" (81 cm)
820M	Foot Medium, for foot sizes up to 13"
820L	Foot Large, for foot sizes up to 16"
830S	Full-Leg Small, for thigh circumference up to 22" (55 cm)
830M	Full-Leg Medium, for thigh circumference up to 29" (73 cm)
830L	Full-Leg Large, for thigh circumference up to 36" (91 cm)
830B	Full-Leg Extra Large, for thigh circumference up to 42" (106 cm)
Air Hose Extension for the DVT Pump:
810	Air hose extension of 59" (Pair)
810L	Air hose extension of 118" (Pair)

MHH900E DVT Pump

7

510(k) Submission

MHH900S/MHH900E DVT Compression Devices

8. Substantial Equivalence [21 CFR807.92 (a) (3) and 807.92]

8.1 Intended uses:

Table 1 Intended Use Comparison

| ID | Comparison
Item | Proposed Device
MedHealth
DVT
Compression Devices
(MHH900S/MHH900E) | Predicate Device
B&J DVT Compression
Device
(MHH800) |
|----|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | 510(K) No. | To be assigned | K200154 |
| 2 | Intended
Use | The MedHealth Medical
Limited. MHH900S and
MHH900E 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 B&J Manufacturing Ltd.
MHH800 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 | Reusable |

It is clear that the intended use of MHH900S and MHH900E is same as the predictive device

MHH800

8.2 Comparison table

Table 2 General Comparison between MHH900S and MHH800

| ID | Comparison
Item | Proposed Device
MedHealth DVT
Compression
Device (MHH900S) | Predicate Device
B&J DVT
Compression
Device (MHH800) | Explanation
of Difference |
|-----|-----------------------|---------------------------------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 5 | General Specification | | | |
| 5.1 | Size | 8.6"x6.2"x8.98" | 6.5"x7.0"x12.8" | Different but
does not raise
any new issue
of substantial
equivalence |

8

MHH900S/MHH900E DVT Compression Devices					510(k) Submission
5.2	Weight	2.48kg	2. 1kg		Different but
does not raise
any new issue
of substantial
equivalence
5.3	Pressure Range	Calf/Thigh:40mmHg;
Foot:120mmHg	Calf/Thigh:40mmHg;
Foot:120mmHg		Same
5.4	Input Rating	AC 100-240V,
50/60Hz	AC 100-240V,
50/60Hz		Same
5.5	Fuse Rating	1A or T1AH 250V	1A or T1AH 250V		Same
5.6	Classification	Class I Type BF
Not AP or AGP
type	Class I Type BF
Not AP or AGP
type
Image: Man in doorway		Same
5.7	Operation
Humidity	30-80%	30-75%	Different but
does not raise
any new issue
of substantial
equivalence
5.8	Storage &
Transportation
Humidity	30-93%	30-75%	Different but
does not raise
any new issue
of substantial
equivalence
5.9	Operation
Temperature	5 ° C-40 ° C	15 ° C-35 ° C	Different but
does not raise
any new issue
of substantial
equivalence
5.10	Storage &
Transportation
Temperature	5 ° C-55 ° C	5 ° C-60 ° C	Different but
does not raise
any new issue
of substantial
equivalence
5.11	Applied Part	Garment(Purchased separately) and Air Hose	Garment(Purchased separately) and Air Hose	Same
5.12	Applied Mode
of Pressure	Intermittent	Intermittent	Same
5.13	Number of
Chambers in
Garment	No	No	Same
5.14	Inflation
chamber
(Calf/Thigh)	12 seconds	12 seconds	Same
5.15	Deflation time
per chamber
(Calf/Thigh)	48 seconds	48 seconds	Same
5.16	Inflation time per
chamber (Foot)	12 seconds	12 seconds	Same
5.17	Deflation time
per chamber
(Foot)	48 seconds	48seconds	Same
5.18	Pressure
Range
Calf/ Thigh	40mmHg	40mmHg	Same
5.19	Pressure Range
Foot	120mmHg	120mmHg	Same
5.20	Pre- Programme
d Controls	Yes	Yes	Same
5.21	Battery Pack	Yes	Yes	Same
5.22	Garments	Purchased separately,
listed
in
510(K)
K201532 & K201547	Purchased separately,
listed
in
510(K)
K201532 & K201547	Same
5.23	Contraindications
for Use	• Severe
congestive cardiac
failure.
• Severe
arteriosclerosis or
other ischemic
vascular disease.
• Extreme
deformity of the
limbs.
• Known or
suspected deep
vein thrombosis.
• Any local
condition in which
the garments would
interfere:

Gangrene
Dermatitis
3)Untreated or
infected wounds
4)Recent skin
grafts | - Severe congestive
cardiac failure.

Severe
arteriosclerosis or
other ischemic
vascular disease.
Extreme deformity
of the limbs.
Known or
suspected deep vein
thrombosis.
Any local condition
in which the
garments would
interfere:
Gangrene
Dermatitis
Untreated or
infected wounds
Recent skin grafts | Same | |

9

510(k) Submission

10

510(k) Submission

11

510(k) Submission

Table3 General Comparison between MHH900E and MHH800

| ID | Compariso
n Item | Proposed Device
MedHealth
DVT
Compression
Device
(MHH900E) | Predicate Device
B&J DVT
Compression
Device
(MHH800) | Explanation of
Difference |
|------|--------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| 5 | General Specification | | | |
| 5.1 | Size | 8.6"x6.2"x8.98" | 6.5"x7.0"x12.8" | Different but
does not raise any
new issue of
substantial
equivalence |
| 5.2 | Weight | 2.48kg | 2.1kg | Different but
does not raise any
new issue of
substantial
equivalence |
| 5.3 | Pressure Range | Calf/Thigh:40mmHg;
Foot:120mmHg | Calf/Thigh:40mmHg;
Foot:120mmHg | Same |
| 5.4 | Input Rating | AC 100-240V,
50/60Hz | AC 100-240V,
50/60Hz | Same |
| 5.5 | Fuse Rating | 1A or T1AH 250V | 1A or T1AH 250V | Same |
| 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 | Same |
| 5.7 | Operation
Humidity | 30-80% | 30-75% | Different but does
not raise any new
issue of
substantial
equivalence |
| 5.8 | Storage &
Transportation
Humidity | 30-93% | 30-75% | Different but does
not raise any new
issue of
substantial
equivalence |
| 5.9 | Operation
Temperature | 5 °C-40 °C | 15 °C-35 °C | Different but does
not raise any new
issue of
substantial
equivalence |
| 5.10 | Storage &
Transportation
Temperature | 5 °C-55 °C | 5 °C-60 °C | Different but
does not raise
any new issue of
substantial
equivalence |
| 5.11 | Applied Part | Garment and Air
Hose | Garment and Air
Hose | Same |
| 5.12 | Applied
Mode
of Pressure | Intermittent | Intermittent | Same |
| 5.13 | Number of
Chambers in
Garment | No | No | Same |
| 5.14 | Inflation
time per
chamber
(Calf/Thigh) | 12 seconds | 12 seconds | Same |
| 5.15 | Deflation time
per chamber
(Calf/Thigh) | 48 seconds | 48 seconds | Same |
| 5.16 | Inflation time per
chamber (Foot) | 12 seconds | 12 seconds | Same |
| 5.17 | Deflation
time
per chamber
(Foot) | 48 seconds | 48seconds | Same |
| 5.18 | Pressure
Range
Calf/Thig
h | 40mmHg | 40mmHg | Same |
| 5.19 | Pressure
Range
Foot | 120mmHg | 120mmHg | Same |
| 5.20 | Pre- Progr
ammed
Controls | Yes | Yes | Same |
| 5.21 | Battery Pack | Yes | Yes | Same |
| 5.22 | Garments | Purchased separately,
listed in 510(K) K201532
& K201547 | Purchased separately,
listed in 510(K) K201532
& K201547 | Same |
| 5.23 | Contraindications for Use | • Severe congestive
cardiac failure.
• Severe
arteriosclerosis or
other ischemic
vascular disease.
• Extreme deformity
of the limbs.
• Known or suspected
deep vein thrombosis.
• Any local condition
in which the garments
would interfere:
• Gangrene
• Dermatitis
• Untreated or
infected wounds
• Recent skin grafts | - Severe congestive
cardiac failure.

Severe
arteriosclerosis or other
ischemic vascular
disease.
Extreme deformity of
the limbs.
Known or suspected
deep vein thrombosis.
Any local condition in
which the garments
would interfere:
Gangrene
Dermatitis
Untreated or infected
wounds
Recent skin grafts | Same |

12

13

It is cleared that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MHH900S and MHH900E

14

8.3 Non-clinical testing [21 CFR 807.92(b) (1)]

The following safety and performance test were conducted to assess MHH900S and MHH900E DVT compression Devices.

A Software validation
Cleaning and Disinfection validation—Testing was performed to, and passed, the A following standards:
- AAMI TIR12: 2020 Designing, Testing And Labeling Reusable Medical Devices For Reprocessing In Health Care Facilities: A Guide For Medical Device Manufacturers

● ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

● AAMI ST98-2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical device

Electromagnetic compatibility and electrical safety-- testing was performed to, and A passed, the following standards:
- IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility -Requirements and tests
- IEC 60601-1-8 Medical electrical equipment –Part 1-8: General requirements for basic safety and essential performance –Collateral standard: General Requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
- IEC TR 60601-4-2:2016 Medical electrical equipment –Part 4-2: Guidance and interpretation Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
A Shelf life (aging test)—Follow ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Device
A Performance test summary:

Testing was performed and to ensure that the system meets its specifications. The manufacturer believes that the technological characteristics of the MHH900H & MHH900S are substantially equivalent to primary predicate and reference device. The functional performance testing includes the following tests:

Pressure accuracy Range-Calf/Thigh Garment
Pressure accuracy Range- Foot Garment
Cycle Time-Inflation
Cycle Time-Deflation
Burst Testing
Pressure Leakage testing

No clinical testing was used to support the decision of safety and effectiveness.

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

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and base on the information provided in this premarket notification, MedHealth Medical Limited concludes that:

The intended use of MHH900S and MHH900E are the same as that of the predicate devices. Demonstrated by the safety and performance tests, the MHH900S/MHH900E are as safe and as effective as the predicate device and therefore are substantially equivalent to the predicate device.