(219 days)
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.
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.
The provided text describes the 510(k) premarket notification for the "DVT Motion Pneumatic Compression Device." This device is a medical device and not an AI/ML-driven diagnostic or treatment system. Therefore, the questions related to AI/ML specific concepts like "acceptance criteria for AI models," "training set," "ground truth establishment," "experts for ground truth," "adjudication methods," and "MRMC comparative effectiveness studies" are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device (VascuEase IC-1200-WH) through non-clinical performance and safety testing, not on the performance of a predictive algorithm.
However, I can extract information related to the device's performance based on the non-clinical testing mentioned.
Here's what can be extracted:
Device Performance and Proof of Meeting Acceptance Criteria
The document states that the "DVT Motion Pneumatic Compression Device meets the requirements of its pre-defined acceptance criteria and intended use" based on a series of non-clinical safety and performance studies. The specific acceptance criteria themselves are not detailed in the provided text, only the tests performed to demonstrate compliance.
1. Table of Acceptance Criteria and Reported Device Performance
As the specific numerical acceptance criteria are not explicitly detailed for each test within the document, I can only provide the types of tests performed and the general statement of compliance.
| Acceptance Criterion (Type of Test) | Reported Device Performance |
|---|---|
| Shelf Life Test | Meets requirements |
| Biocompatibility (In Vitro Cytotoxicity, Skin Sensitization, Skin Irritation) | Meets requirements |
| Software Validation | Meets requirements |
| Electromagnetic Compatibility and Electrical Safety | Meets requirements |
| Performance (Alert Test, Discharge and Charge, Inflation and Deflation Time Test, System Leakage Test, System Pressure Test) | Meets requirements |
| Usability Test | Meets requirements |
| Cycle Time | 60 ± 10 seconds (Inflation: 15 seconds; Deflation: 45 seconds) – Matches predicate |
| Pressure | 50 mmHg ± 20% – Matches predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for individual non-clinical tests. The tests were performed on the device itself.
- Data Provenance: The tests were conducted on the "subject device" (DVT Motion Pneumatic Compression Device) by Koge Micro Tech Co., Ltd. The document does not specify the country of origin of the labs, but Koge Micro Tech Co., Ltd. is located in Taiwan. These were prospective tests performed on the device to demonstrate its performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable: This is a physical medical device clearance, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for these tests comes from engineering standards and measurements, not human interpretation of data.
4. Adjudication Method for the Test Set
- Not Applicable: As above, this does not involve human adjudication for a test set in the context of an AI/ML model.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, Not Applicable: No MRMC study was performed as this is not an AI/ML diagnostic or image analysis device. The study type was non-clinical testing against engineering standards and comparison to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an algorithm. The "software validation" mentioned refers to the software controlling the pneumatic compression device, ensuring its proper functioning, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used
- "Ground truth" was established by predefined engineering standards and test methodology. For example, pressure measurements are compared against a specified mmHg range, and cycle times against a target duration. The document states that "All the test results demonstrate DVT Motion Pneumatic Compression Device meets the requirements of its pre-defined acceptance criteria and intended use."
8. The Sample Size for the Training Set
- Not Applicable: There is no "training set" in the AI/ML sense for this device.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: There is no "training set" for this device.
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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).
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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 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
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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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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 City23586, 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 Submissions | New 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 |
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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
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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.
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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.
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| Subject Device | Predicate Device | Substantial EquivalenceDiscussion | |
|---|---|---|---|
| Koge Micro Tech Co., Ltd.DVT Motion Pneumatic Compression Device | Bio Compression Systems, Inc.VascuEase IC-1200-WH | Traditional 510(k)_K232270.IR1Attachment 2 - Section 5 (revised) | |
| (to be assigned) | K180248 | ||
| DVT Motion Pneumatic Compression Deviceis 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
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Koge Micro Tech Co., Ltd.
DVT Motion Pneumatic Compression Devic
Traditional 510(k)_K232270.IR1
Attachment 2 - Section 5 (revised)
| Item | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Subject Device | Predicate Device | Substantial Equivalence | ||||||||||||||||
| Manufacturer | Koge Micro Tech Co., Ltd. | Bio Compression Systems, Inc. | Discussion | |||||||||||||||
| Trade Name | DVT Motion Pneumatic Compression Device | VascuEase IC-1200-WH | performances of the subject device are not affected and meet the requirements. Therefore, it would not affect the equivalence. | |||||||||||||||
| 510(k) No. | (to be assigned) | K180248 | Different but the performances of the subject device are not affected and meet the requirements. Therefore, it would not affect the equivalence. | Same | ||||||||||||||
| Dimensions | 140 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 ofSegments ingarment | 1 | 1 |
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Koge Micro Tech Co., Ltd.
DVT Motion Pneumatic Compression Devic
Traditional 510(k)_K232270.IR1
Attachment 2 - Section 5 (revised
| Item | Manufacturer | Trade Name | 510(k) No. | Cycle Time | Pressure | Pressure Adjustment | Pressure Display | Power Requirement | Mobility | Predicate Device | Substantial Equivalence Discussion |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Koge Micro Tech Co., Ltd. | DVT Motion Pneumatic Compression Device | (to be assigned) | 60 ± 10 seconnds | 50 mmHg ± 20 % | N/A | No | Rechargeable battery | Portable, worn | Bio Compression Systems, Inc. | ||
| (Inflation time: 15 seconds;Deflation time: 45 seconds) | 50 mmHg | N/A | No | Rechargeable battery | Portable, worn | VascuEase IC-1200-WH | Same | ||||
| K180248 | Inflation Time: 15 secondsDeflation Time: 45 seconds | Same | |||||||||
| Same | |||||||||||
| Same | |||||||||||
| Same |
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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.
§ 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).