K Number
K232270
Device Name
DVT Motion Pneumatic Compression Device
Date Cleared
2024-03-06

(219 days)

Product Code
Regulation Number
870.5800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
DVT Motion Pneumatic Compression Device is a prescription device intended for prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.
Device Description
The DVT Motion Pneumatic Compression Device is a portable, rechargeable battery-powered device intended for prescribed home use or hospital use to help prevent Deep Vein Thrombosis (DVT) in patients by stimulating blood flow. This is accomplished using an electronically controlled pump delivering a set amount of air to the leg garment that compresses the calf and aids blood flow through the lower extremities. The pump will inflate to a preset pressure of 50mmHg and deflate once this pressure is reached. The cycle continues until the unit is turned off. The tube free solution comes complete with a fully integrated lithium ion battery that supplies over 18 hours of treatment on a single charge, assuring that patients can be transported easily from the hospital to their homes without interruptions in treatment.
More Information

Not Found

No
The description details a simple pneumatic compression device with an electronically controlled pump and preset pressure. There is no mention of AI/ML terms, image processing, or data sets for training/testing, which are typical indicators of AI/ML integration.

Yes.
The device's intended use clearly states that it is for "prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures," all of which are therapeutic purposes.

No

The device description indicates it is a "Pneumatic Compression Device" used for prophylaxis and stimulation of circulation, not for diagnosing conditions.

No

The device description explicitly states it is a "portable, rechargeable battery-powered device" with an "electronically controlled pump" and "leg garment," indicating it includes significant hardware components beyond just software.

Based on the provided information, the DVT Motion Pneumatic Compression Device is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use clearly states the device is for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating circulation, aiding in ulcer prevention and healing, and reducing edema and compartmental pressures. These are all therapeutic and preventative actions performed on the patient's body.
  • Device Description: The description details a pneumatic compression device that applies pressure to the calf to aid blood flow. This is a physical intervention, not a test performed on a sample taken from the body.
  • Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on in vitro testing.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

N/A

Intended Use / Indications for Use

DVT Motion Pneumatic Compression Device is a prescription device intended for prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.

Product codes

JOW

Device Description

The DVT Motion Pneumatic Compression Device is a portable, rechargeable battery-powered device intended for prescribed home use or hospital use to help prevent Deep Vein Thrombosis (DVT) in patients by stimulating blood flow.

This is accomplished using an electronically controlled pump delivering a set amount of air to the leg garment that compresses the calf and aids blood flow through the lower extremities.

The pump will inflate to a preset pressure of 50mmHg and deflate once this pressure is reached. The cycle continues until the unit is turned off.

The tube free solution comes complete with a fully integrated lithium ion battery that supplies over 18 hours of treatment on a single charge, assuring that patients can be transported easily from the hospital to their homes without interruptions in treatment.

Package contents:

  • a pair of DVT Motion Pneumatic Compression Pumps
  • a pair of leg garments
  • a charger (including an adaptor)
  • a set of instructions

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

Home or hospital setting.

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)

A series of non-clinical safety and performance studies were conducted on the subject device. The following tests and studies were according to the related recognized consensus standards.

  • Shelf Life Test
  • Biocompatibility
    • In Virto Cytotoxicity Test
    • Skin Sensitization Study
    • Skin Irritation Test
  • Software Validation
  • Electromagnetic compatibility and electrical safety
  • Performance
    • Alert Test
    • Discharge and Charge
    • Inflation and Deflation Time Test
    • System Leakage Test
    • System Pressure Test
  • Usability test

All the test results demonstrate DVT Motion Pneumatic Compression Device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of the finished DVT Motion Pneumatic Compression Device have been established through previous non-clinical performance testing.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K180248

Reference Device(s)

Not Found

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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

March 6, 2024

Koge Micro Tech Co., Ltd. Doris Chiu Regulatory Affairs 5F., No. 6, Jiankang Rd. 1, Zhonghe Dist. New Taipei. 23586 Taiwan

Re: K232270

Trade/Device Name: DVT Motion Pneumatic Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 29, 2024 Received: February 7, 2024

Dear Doris Chiu:

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 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,

Nicole M. Gillette -S

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

2

Indications for Use

510(k) Number (if known) K232270

Device Name

DVT Motion Pneumatic Compression Device

Indications for Use (Describe)

DVT Motion Pneumatic Compression Device is a prescription device intended for prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.

Type of Use (Select one or both, as applicable)
-------------------------------------------------
Research Use (Part 21 CFR 50 Subpart D)
Gene Therapy Use (21 CFR 601 Subpart E)

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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3

Koge Micro Tech Co., Ltd. DVT Motion Pneumatic Compression Device

Traditional 510(k)_K232270.IR1 Attachment 2 - Section 5 (revised)

510(k) SUMMARY

5.1 Traditional Type of Submission:

  • 5.2 Date of Summary: 03/04/2024
  • 5.3 Submitter: Koge Micro Tech Co., Ltd.

| Address: | 5F., No. 6, Jiankang Rd. 1, Zhonghe Dist., New Taipei City
23586, Taiwan (R.O.C) |
|----------|-------------------------------------------------------------------------------------|
| Phone: | +886-2-77381338 |
| Contact: | Doris Chiu
(doris_chiu@koge.com) |

5.4 Identification of the Device:

Proprietary/Trade name:DVT Motion Pneumatic Compression Device
Classification Product Code:JOW
Regulation Number:870.5800
Regulation Description:Sleeve, Limb, Compressible
Review Panel:Cardiovascular
Device Class:II
Basis for the SubmissionsNew Device

5.5 Identification of the Predicate Device:

Predicate Device Name:VascuEase IC-1200-WH
Applicant:Bio Compression Systems. Inc.
Classification Product Code:JOW
Regulation number:870.5800
Device Class:II
510(k) Number:K180248

4

5.6 Indications for Use / Intended Use of the Device

DVT Motion Pneumatic Compression Device is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting.

5.7 Description of the Device

The DVT Motion Pneumatic Compression Device is a portable, rechargeable battery-powered device intended for prescribed home use or hospital use to help prevent Deep Vein Thrombosis (DVT) in patients by stimulating blood flow.

This is accomplished using an electronically controlled pump delivering a set amount of air to the leg garment that compresses the calf and aids blood flow through the lower extremities.

The pump will inflate to a preset pressure of 50mmHg and deflate once this pressure is reached. The cycle continues until the unit is turned off.

The tube free solution comes complete with a fully integrated lithium ion battery that supplies over 18 hours of treatment on a single charge, assuring that patients can be transported easily from the hospital to their homes without interruptions in treatment.

Package contents:

  • . a pair of DVT Motion Pneumatic Compression Pumps
  • a pair of leg garments
  • . a charger (including an adaptor)
  • a set of instructions

5

Koge Micro Tech Co., Ltd. DVT Motion Pneumatic Compression Device

5.8 Non-clinical Testing

A series of non-clinical safety and performance studies were conducted on the subject device. The following tests and studies were according to the related recognized consensus standards.

  • Shelf Life Test
  • Biocompatibility
    • In Virto Cytotoxicity Test
    • Skin Sensitization Study i
    • Skin Irritation Test i
  • Software Validation
  • Electromagnetic compatibility and electrical safety
  • Performance
    • Alert Test
    • Discharge and Charge
    • Inflation and Deflation Time Test -
    • System Leakage Test i
    • System Pressure Test i
  • . Usability test

All the test results demonstrate DVT Motion Pneumatic Compression Device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.

5.9 Clinical Testing

No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of the finished DVT Motion Pneumatic Compression Device have been established through previous non-clinical performance testing.

6

Substantial Equivalence Determination 5.10

The DVT Motion Pneumatic Compression Device submitted in this 510(k) file is substantially equivalent in intended use, safety and performance claims to the cleared device, VascuEase IC-1200-WH (K180248). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.

7

| | Subject Device | Predicate Device | Substantial Equivalence
Discussion |
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| | Koge Micro Tech Co., Ltd.
DVT Motion Pneumatic Compression Device | Bio Compression Systems, Inc.
VascuEase IC-1200-WH | Traditional 510(k)_K232270.IR1
Attachment 2 - Section 5 (revised) |
| | (to be assigned) | K180248 | |
| | DVT Motion Pneumatic Compression Device
is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in the prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting. | VascuEase is a prescription device intended for the prophylaxis of Deep Vein Thrombosis (DVT), stimulating venous and arterial circulation, aiding in prevention of venous stasis ulcers, aiding in the healing of cutaneous ulcers, reducing acute/chronic edema and compartmental pressures. For use in home or hospital setting. | Same |
| | Intermittent Pneumatic Compression | Intermittent Pneumatic Compression | Same |
| | Prescription Use | Prescription Use | Same |
| | $260 g \pm 30 g$
$(0.57 \pm 0.066 pounds)$ | 0.7 pounds | Different but Equivalent |

6/9

8

Koge Micro Tech Co., Ltd.
DVT Motion Pneumatic Compression Devic

Traditional 510(k)_K232270.IR1
Attachment 2 - Section 5 (revised)

Item
Subject DevicePredicate DeviceSubstantial Equivalence
ManufacturerKoge Micro Tech Co., Ltd.Bio Compression Systems, Inc.Discussion
Trade NameDVT Motion Pneumatic Compression DeviceVascuEase IC-1200-WHperformances of the subject device are not affected and meet the requirements. Therefore, it would not affect the equivalence.
510(k) No.(to be assigned)K180248Different but the performances of the subject device are not affected and meet the requirements. Therefore, it would not affect the equivalence.Same
Dimensions140 mm x 77 mm x 40 mm
(5.51 x 3.03 x 1.57 inches)5.3 x 2.7 x 1.5 inches
Number of
Segments in
garment11

9

Koge Micro Tech Co., Ltd.
DVT Motion Pneumatic Compression Devic

Traditional 510(k)_K232270.IR1
Attachment 2 - Section 5 (revised

ItemManufacturerTrade Name510(k) No.Cycle TimePressurePressure AdjustmentPressure DisplayPower RequirementMobilityPredicate DeviceSubstantial Equivalence Discussion
Koge Micro Tech Co., Ltd.DVT Motion Pneumatic Compression Device(to be assigned)60 ± 10 seconnds50 mmHg ± 20 %N/ANoRechargeable batteryPortable, wornBio Compression Systems, Inc.
(Inflation time: 15 seconds;
Deflation time: 45 seconds)50 mmHgN/ANoRechargeable batteryPortable, wornVascuEase IC-1200-WHSame
K180248Inflation Time: 15 seconds
Deflation Time: 45 secondsSame
Same
Same
Same

10

5.11 Similarity and Difference

The DVT Motion Pneumatic Compression Device is compared with VascuEase IC-1200-WH. The subject device has same intended use, principal of operation, type of use and performance, and similar safety with the predicate device. No specifications are significantly different between these two devices.

Furthermore, the subject device has undergone other safety and performance tests, and the results complied with the testing standards. Therefore, any differences between the subject device and the predicate device are insignificant and do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device as it claims.

5.12 Conclusion

After analyzing non-clinical laboratory studies, safety and performance testing data, it can be concluded that the DVT Motion Pneumatic Compression Device is substantially equivalent to the predicate device.