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.

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 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.

AI/ML Overview

The provided text describes the MedHealth DVT compression Devices MHH900S/MHH900E and their substantial equivalence to a predicate device (B&J Manufacturing Ltd. Deep Vein Thrombosis (DVT) compression device MHH800 (K200154)). Since this is a submission for substantial equivalence based on non-clinical testing, it does not involve AI or studies with human readers. Therefore, several points in your request are not applicable.

Here's the breakdown of the information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of specifications between the proposed devices (MHH900S/MHH900E) and the predicate device (MHH800), and states that non-clinical testing was performed to ensure the system meets its specifications. The specific acceptance criteria for each test are not explicitly stated in a quantified manner, but the document confirms that the device "passed" these tests.

Acceptance Criteria (Implied)	Reported Device Performance (MHH900S/MHH900E)
Software Validation	Passed
Cleaning and Disinfection Validation (AAMI TIR12:2020, ASTM F3208-20, AAMI ST98-2022)	Passed (to these standards)
Electromagnetic Compatibility and Electrical Safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC TR 60601-4-2:2016)	Passed (to these standards)
Shelf Life (Aging Test) (ASTM F1980-21)	Performed (and presumably passed based on overall conclusion of safety and effectiveness)
Performance Test Summary:
- Pressure Accuracy Range - Calf/Thigh Garment	Meets specifications (presumably 40mmHg +10/-5mmHg)
- Pressure Accuracy Range - Foot Garment	Meets specifications (presumably 120mmHg +10/-5mmHg)
- Cycle Time - Inflation	Meets specifications (presumably 12 seconds +/- 1 second)
- Cycle Time - Deflation	Meets specifications (presumably 48 seconds +/- 2 seconds)
- Burst Testing	Performed (and presumably passed)
- Pressure Leakage Testing	Performed (and presumably passed)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to non-clinical testing (software validation, cleaning, electrical safety, shelf life, and functional performance testing). These tests typically involve physical units of the device or software code, not patient data. Therefore, "sample size for the test set" and "data provenance" in the context of clinical data are not applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the submission is for a medical device that does not involve expert-mediated ground truth (like image interpretation by radiologists). The tests are based on engineering and performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable, as there is no expert adjudication in a non-clinical device testing context.

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

This is not applicable. The device is a "Deep Vein Thrombosis (DVT) compression device," which is a physical medical device (pneumatic compression) and not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable, as the device is not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical tests, the "ground truth" is defined by the relevant international and national standards (e.g., AAMI, ASTM, IEC) against which the device's performance is measured. For example, for pressure accuracy, the ground truth is the specified pressure range (e.g., 40 mmHg +10/-5mmHg).

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI model that requires a training set.

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

This is not applicable, as there is no training set for this device.

Summary

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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).

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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

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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.

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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)]

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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.

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.

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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/-5mmHgFoot Garment: 120mmHg +10/-5mmHg
Input Rating	AC 100V-240V 50/60Hz 1A
Fuse Rating	1A or T1AH 250V
Classification	Class I Type BFNot AP or AGP type
Humidity	Operation: 30% to 80 %Storage & Transportation: 30% to 93%
Air pressure	75 - 106KPA
Temperature	Operation: 5° C- 40° CStorage & Transportation: 5° C - 55° C
Cycle Time	Inflation 12 seconds +/- 1 secondDeflation 48 seconds +/- 2 seconds
Applied Part	Garments (Purchased separately) and Air Tube
Battery	Battery pack: 4 x series Li-ion battery cellBattery pack capacity: 2900mAh (Nominal),2700mAh (minimum)Nominal voltage: 14.4VTemperature: 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)

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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/-5mmHgFoot Garment: 120mmHg +10/-5mmHg
Input Rating	AC 100V-240V 50/60Hz 1A
Fuse Rating	1A or T1AH 250V
Classification	Class I Type BFNot AP or AGP typeImage: [Person Symbol]
Humidity	Operation: 30% to 80 %Storage & Transportation: 30% to 93%
Air pressure	75 - 106KPA
Temperature	Operation: 5° C- 40° CStorage & Transportation: 5° C - 55° C
Cycle Time	Inflation 12 seconds +/- 1 secondDeflation 48 seconds +/- 2 seconds
Applied Part	Garments (Purchased separately) and Air Tub
Battery	Battery pack: 4 x series Li-ion battery cellBattery pack capacity: 2900mAh (Nominal),2700mAh (minimum)Nominal voltage: 14.4VTemperature: 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

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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	ComparisonItem	Proposed DeviceMedHealthDVTCompression Devices(MHH900S/MHH900E)	Predicate DeviceB&J DVT CompressionDevice(MHH800)
1	510(K) No.	To be assigned	K200154
2	IntendedUse	The MedHealth MedicalLimited. MHH900S andMHH900E Deep VeinThrombosis (DVT)Compression Devices areintended to increase venousblood flow in at risk patientsin order to help prevent deepvein thrombosis.	The B&J Manufacturing Ltd.MHH800 Deep VeinThrombosis (DVT)Compression Devices areintended to increase venousblood flow in at risk patientsin order to help prevent deepvein 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	ComparisonItem	Proposed DeviceMedHealth DVTCompressionDevice (MHH900S)	Predicate DeviceB&J DVTCompressionDevice (MHH800)	Explanationof Difference
5	General Specification
5.1	Size	8.6"x6.2"x8.98"	6.5"x7.0"x12.8"	Different butdoes not raiseany new issueof substantialequivalence

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MHH900S/MHH900E DVT Compression Devices					510(k) Submission
5.2	Weight	2.48kg	2. 1kg		Different butdoes not raiseany new issueof substantialequivalence
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 BFNot AP or AGPtype	Class I Type BFNot AP or AGPtypeImage: Man in doorway		Same
5.7	OperationHumidity	30-80%	30-75%	Different butdoes not raiseany new issueof substantialequivalence
5.8	Storage &TransportationHumidity	30-93%	30-75%	Different butdoes not raiseany new issueof substantialequivalence
5.9	OperationTemperature	5 ° C-40 ° C	15 ° C-35 ° C	Different butdoes not raiseany new issueof substantialequivalence
5.10	Storage &TransportationTemperature	5 ° C-55 ° C	5 ° C-60 ° C	Different butdoes not raiseany new issueof substantialequivalence
5.11	Applied Part	Garment(Purchased separately) and Air Hose	Garment(Purchased separately) and Air Hose	Same
5.12	Applied Modeof Pressure	Intermittent	Intermittent	Same
5.13	Number ofChambers inGarment	No	No	Same
5.14	Inflationchamber(Calf/Thigh)	12 seconds	12 seconds	Same
5.15	Deflation timeper chamber(Calf/Thigh)	48 seconds	48 seconds	Same
5.16	Inflation time perchamber (Foot)	12 seconds	12 seconds	Same
5.17	Deflation timeper chamber(Foot)	48 seconds	48seconds	Same
5.18	PressureRangeCalf/ Thigh	40mmHg	40mmHg	Same
5.19	Pressure RangeFoot	120mmHg	120mmHg	Same
5.20	Pre- Programmed Controls	Yes	Yes	Same
5.21	Battery Pack	Yes	Yes	Same
5.22	Garments	Purchased separately,listedin510(K)K201532 & K201547	Purchased separately,listedin510(K)K201532 & K201547	Same
5.23	Contraindicationsfor Use	• Severecongestive cardiacfailure.• Severearteriosclerosis orother ischemicvascular disease.• Extremedeformity of thelimbs.• Known orsuspected deepvein thrombosis.• Any localcondition in whichthe garments wouldinterfere:1) Gangrene2) Dermatitis3)Untreated orinfected wounds4)Recent skingrafts	- Severe congestivecardiac failure.- Severearteriosclerosis orother ischemicvascular disease.- Extreme deformityof the limbs.- Known orsuspected deep veinthrombosis.- Any local conditionin which thegarments wouldinterfere:- Gangrene- Dermatitis- Untreated orinfected wounds- Recent skin grafts	Same

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510(k) Submission

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510(k) Submission

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510(k) Submission

Table3 General Comparison between MHH900E and MHH800

ID	Comparison Item	Proposed DeviceMedHealthDVTCompressionDevice(MHH900E)	Predicate DeviceB&J DVTCompressionDevice(MHH800)	Explanation ofDifference
5	General Specification
5.1	Size	8.6"x6.2"x8.98"	6.5"x7.0"x12.8"	Different butdoes not raise anynew issue ofsubstantialequivalence
5.2	Weight	2.48kg	2.1kg	Different butdoes not raise anynew issue ofsubstantialequivalence
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 BFNot AP or AGPtypeImage: Man in wheelchair	Class I Type BFNot AP or AGPtypeImage: Man in wheelchair	Same
5.7	OperationHumidity	30-80%	30-75%	Different but doesnot raise any newissue ofsubstantialequivalence
5.8	Storage &TransportationHumidity	30-93%	30-75%	Different but doesnot raise any newissue ofsubstantialequivalence
5.9	OperationTemperature	5 °C-40 °C	15 °C-35 °C	Different but doesnot raise any newissue ofsubstantialequivalence
5.10	Storage &TransportationTemperature	5 °C-55 °C	5 °C-60 °C	Different butdoes not raiseany new issue ofsubstantialequivalence
5.11	Applied Part	Garment and AirHose	Garment and AirHose	Same
5.12	AppliedModeof Pressure	Intermittent	Intermittent	Same
5.13	Number ofChambers inGarment	No	No	Same
5.14	Inflationtime perchamber(Calf/Thigh)	12 seconds	12 seconds	Same
5.15	Deflation timeper chamber(Calf/Thigh)	48 seconds	48 seconds	Same
5.16	Inflation time perchamber (Foot)	12 seconds	12 seconds	Same
5.17	Deflationtimeper chamber(Foot)	48 seconds	48seconds	Same
5.18	PressureRangeCalf/Thigh	40mmHg	40mmHg	Same
5.19	PressureRangeFoot	120mmHg	120mmHg	Same
5.20	Pre- ProgrammedControls	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 congestivecardiac failure.• Severearteriosclerosis orother ischemicvascular disease.• Extreme deformityof the limbs.• Known or suspecteddeep vein thrombosis.• Any local conditionin which the garmentswould interfere:• Gangrene• Dermatitis• Untreated orinfected wounds• Recent skin grafts	- Severe congestivecardiac failure.- Severearteriosclerosis or otherischemic vasculardisease.- Extreme deformity ofthe limbs.- Known or suspecteddeep vein thrombosis.- Any local condition inwhich the garmentswould interfere:- Gangrene- Dermatitis- Untreated or infectedwounds- Recent skin grafts	Same

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

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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.

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).