(225 days)
The Pegasus Medical Supply Inc. ANGIO-PRESS LITE DVT Compression Device is intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.
The ANGIO-PRESS LITE DVT Compression Device is a non-invasive intermittent pneumatic compression system that aids in prevention and reduction in incidence of deep vein thrombosis (DVT). The system consists of a pump and soft pliable compression single patient use garments for leg or foot compression. The pump supplies compression on a pre-set inflation pressure of 40mmHg for calf and thigh compression, and 80mmHg for foot compression. Pressure in the garments is transferred to the extremities, augmenting venous blood flow, thus reducing stasis.
The provided text is a 510(k) Summary for a medical device called "ANGIO-PRESS LITE DVT Compression Device." This document details the application for marketing clearance based on substantial equivalence to a predicate device.
It's crucial to understand that this document does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm or diagnostic accuracy testing. Instead, it describes non-clinical testing to demonstrate that the device, a physical medical apparatus, meets pre-defined acceptance criteria for its physical and functional performance, ensuring its safety and effectiveness compared to a previously cleared device.
Therefore, many of the requested elements pertaining to AI/ML model validation (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable to this type of medical device submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "All the test results demonstrate ANGIO-PRESS LITE DVT Compression Device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device."
However, it does not provide a specific table of acceptance criteria with corresponding performance values for each non-clinical test. It lists the types of non-clinical tests conducted:
| Non-clinical Test Type | Implied Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials are biocompatible and do not cause adverse reactions. | "All the test results demonstrate ANGIO-PRESS LITE DVT Compression Device meets the requirements of its pre-defined acceptance criteria..." (Specific results not detailed in this summary) |
| Software Validation | Software functions as intended, is reliable, and does not pose safety risks. | As above. The software differences (w/o Timer and Pressure display, w/o Reset Timer function) are acknowledged and deemed not to impact safety/effectiveness compared to the predicate's software (w/ Timer and Pressure display, w/ Reset Timer function). |
| Electromagnetic compatibility (EMC) & electrical safety | Device operates without electromagnetic interference and meets electrical safety standards. | As above. It notes differences in IEC Classification (Class II, Type BF vs. Class I, Type BF), and Input Rating (AC 110-120V vs. AC 100-240V), Fuse Rating (T1AL 250V vs. 1A/250V), and Ingress of Water Protection (IP21 vs. N/A), but asserts these do not impact safety/effectiveness. |
| Reliability | Device maintains consistent performance over time and usage. | As above. |
| Performance (Functional) | Device achieves specified pressure, inflation/deflation times, and airflow. | Pressure Range: Calf/Thigh: 40 mmHg; Foot: 80 mmHg (Same as predicate) Inflation time per chamber: 12 seconds (Same as predicate) Deflation time per chamber: 48 seconds (Same as predicate) Airflow: ≥ 6.0 L/min (Same as predicate) "All the test results demonstrate ANGIO-PRESS LITE DVT Compression Device meets the requirements of its pre-defined acceptance criteria..." |
| Usability | Device is safe and effective for users, minimizing errors. | As above. |
Note: The document explicitly states: "Differences between the devices cited in this section do not raise any new issue of substantial equivalence." and "the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device."
2. Sample size used for the test set and the data provenance
This is not applicable in the context of an AI/ML algorithm's test set. The non-clinical tests relate to the physical device's performance, durability, and safety. There is no "test set" of patient data in the sense of an algorithm's evaluation.
Data provenance: Not applicable in this context. The testing would have been done by or on behalf of the manufacturer, Pegasus Medical Supply, Inc. in Taiwan.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as there is no "ground truth" to establish for a physical DVT compression device's performance in the same way there would be for an AI diagnostic algorithm. The acceptance criteria for the physical tests are based on engineering specifications, regulatory standards, and comparison to the predicate device's established performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used to resolve discrepancies in expert labeling or diagnoses for AI training/test sets.
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. This device is a physical DVT compression device, not an AI/ML 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. This device is not an algorithm. Its performance is inherent in its mechanical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests mentioned, the "ground truth" implicitly refers to engineering specifications, regulatory standards (e.g., electrical safety, biocompatibility standards), and the established performance parameters of the predicate device. For example, for pressure or flow rate, the "ground truth" is a measured value against a pre-defined range or target.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device.
In summary: The provided document is a 510(k) Summary for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing. The questions posed are primarily relevant for AI/ML-based medical devices or diagnostic tools, which is why most are not applicable to the "ANGIO-PRESS LITE DVT Compression Device." The "acceptance criteria" here refer to satisfying engineering specifications and regulatory safety standards, validated through a series of defined physical and electrical tests.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 10, 2018
Pegasus Medical Supply, Inc. Pao-Ming Shih General Manager No. 27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli City Taoyuan County, 32060 Tw
Re: K173012
Trade/Device Name: ANGIO-PRESS LITE DVT Compression Device Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 17, 2018 Received: April 18, 2018
Dear Pao-Ming Shih:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 G. Ibrahim -S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name ANGIO-PRESS LITE DVT Compression Device
Indications for Use (Describe)
The Pegasus Medical Supply Inc. ANGIO-PRESS LITE DVT Compression Device is intended to increase venous blood flow in 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) | ☐ |
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Pegasus Medical Supply, Inc. ANGIO-PRESS LITE DVT Compression Device Traditional 510(k), K173012/S003 Section 5 - 510(k) Summary
510(k) SUMMARY
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Date of Summary: | May 9, 2018 |
| 5.3 | Submitter:Address: | Pegasus Medical Supply, Inc.No.27-1, Ln. 473, Sec. 2, Hezun N. Rd., Zhongli |
| City, Taoyuan County 32060, Taiwan (R.O.C.) | ||
| Phone: | +886-3-2753341 | |
| Fax: | +886-3-4616802 | |
| Contact: | PAO-MING SHIH | |
| (borisshih(@pegasus-pms.com) |
5.4 Identification of the Device:
| Proprietary/Trade name: | ANGIO-PRESS LITE DVT | |
|---|---|---|
| Compression Device | ||
| Classification Product Code: | JOW | |
| Regulation Number: | 870.5800 | |
| Regulation Description: | Compressible limb sleeve | |
| Review Panel: | Cardiovascular | |
| Device Class: | II |
Identification of the Predicate Device: 5.5
| Predicate Device Name: | ANGIO-PRESS DVT Compression |
|---|---|
| Device Model Name: IPCS | |
| Manufacturer: | Pegasus Medical Supply, Inc. |
| Classification Product Code: | JOW |
| Regulation number: | 870.5800 |
| Device Class: | II |
| 510(k) Number: | K143202 |
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5.6 Intended Use/ Indications for Use of the Device
The Pegasus Medical Supply Inc. ANGIO-PRESS LITE DVT Compression Device is intended to increase venous blood flow in patients in order to help prevent deep vein thrombosis.
5.7 Device Description
The ANGIO-PRESS LITE DVT Compression Device is a non-invasive intermittent pneumatic compression system that aids in prevention and reduction in incidence of deep vein thrombosis (DVT).
The system consists of a pump and soft pliable compression single patient use garments for leg or foot compression. The pump supplies compression on a pre-set inflation pressure of 40mmHg for calf and thigh compression, and 80mmHg for foot compression. Pressure in the garments is transferred to the extremities, augmenting venous blood flow, thus reducing stasis.
5.8 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, ANGIO-PRESS LITE DVT Compression Device.
- . Biocompatibility
- Software Validation
- . Electromagnetic compatibility and electrical safety
- Reliability
- . Performance
- . Usability
All the test results demonstrate ANGIO-PRESS LITE DVT Compression Device meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
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5.9 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
5.10 Substantial Equivalence Determination
The ANGIO-PRESS LITE DVT Compression Device submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared ANGIO-PRESS DVT Compression Device Model Name: IPCS (K143202). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
|---|---|---|---|
| Proprietary Name | ANGIO-PRESS LITE DVTCompression Device | ANGIO-PRESS DVT CompressionDevice | N/A |
| Model Name | ANGIO-PRESS LITE | IPCS | |
| 510(k) No. | (to be assigned) | K143202 | |
| Intended Use | The Pegasus Medical Supply Inc.ANGIO-PRESS LITE DVTCompression Device is intended toincrease venous blood flow inpatients in order to help preventdeep vein thrombosis. | The Pegasus Medical Supply Inc.ANGIO-PRESS IPCS Deep VeinThrombosis (DVT) CompressionDevices is intended to increasevenous blood flow in patients inorder to help prevent deep veinthrombosis. | Same |
| Type of use | Prescription Use | Prescription Use | Same |
| For Control Unit (Pump) | |||
| Size (L x W x H) | 26 x 10.5 x 16 cm | 31.5 x 11 x 19.5 cm(12.6" x 4.3" x 7.7") | Different but doesnot impact safetyand effectivenessof subject device |
| Weight | 2.5 Kg | 3.1 Kg | Different but does |
| not impact safetyand effectivenessof subject device | |||
| Pressure Range | Calf/Thigh: 40 mmHgFoot: 80 mmHg | Calf/Thigh: 40 mmHgFoot: 80 mmHg | Same |
| Input Rating | AC 110-120V, 60Hz | AC 100-240V, 50/60Hz | Different but doesnot impact safetyand effectivenessof subject device |
| Fuse Rating | T1AL 250V | 1A/250V | Different but doesnot impact safetyand effectivenessof subject device |
| IEC Classification | Class II, Type BFNot AP or AGP type | Class I Type BFNot AP or APG type | Different but doesnot impact safetyand effectivenessof subject device |
| Ingress of WaterProtection | IP21 | N/A | Different but doesnot impact safetyand effectivenessof subject device |
| Operation Humidity | 30% to 75% non-condensing | 30 - 75% | Same |
| OperationTemperature | 15°C - 40°C | 15°C - 35°C | Different but doesnot impact safetyand effectivenessof subject device |
| OperationAtmosphericPressure Range | 700 hPa to 1060 hPa | 700 hPa to 1060 hPa | Same |
| Mode of Operation | Continuous | Continuous | Same |
| Applied Part | Garment and Air Tubing | Garment and Air Hose | Same |
| Applied Mode of | Intermittent | Intermittent | Same |
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Pegasus Medical Supply, Inc.
ANGIO-PRESS LITE DVT Compression Device
Traditional 510(k), K173012/S003
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Pegasus Medical Supply, Inc.
ANGIO-PRESS LITE DVT Compression Device
Traditional 510(k), K173012/S003
| Pressure | |||||
|---|---|---|---|---|---|
| Inflation time | 12 seconds | 12 seconds | Same | ||
| per chamber | |||||
| Deflation time | 48 seconds | 48 seconds | Same | ||
| per chamber | |||||
| Airflow | ≧ 6.0 L/min | ≧ 6.0 L/min | Same | ||
| Software | Different but does | ||||
| w/o Timer and Pressure display | w/ Timer and Pressure display | not impact safety | |||
| Control Panel | w/o Reset Timer function | w/ Reset Timer function | and effectiveness | ||
| of subject device | |||||
| For Applied Part | |||||
| Calf Garments(For calfcircumference)Thigh Garments(For thighcircumference) | Small | Up to 14" | Extra Small | 35 cm | |
| (XS) | |||||
| MediumLarge | Up to 18"Up to 24" | Small | 43 cm | Different but does | |
| (名) | not impact safety | ||||
| Medium(M) | 48 cm | and effectivenessof subject device | |||
| BariatricMedium | Up to 32"Up to 29" | Bariatric | 81 cm71 cm | ||
| (B) | |||||
| Medium | Different but does | ||||
| (M) | not impact safety | ||||
| Large | Up to 36" | Large | 89 cm | and effectiveness | |
| Bariatric | Up to 42" | (L) | of subject device | ||
| Foot Garments(For US men's size) | Standard | Up to 13 | Regular | Size 7 - 9 | Different but does |
| (U) | not impact safety | ||||
| Large | Over 13 | Large | Size 9 - 11 | and effectiveness | |
| (L) | of subject device | ||||
| Air Tubing /Air Hose | Replacement tubing, 60" and 120" | Air hose extension of1.5, 3, and 4.5 metres | Different but does | ||
| not impact safety | |||||
| and effectiveness | |||||
| of subject device |
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5.11 Similarity and Difference
The ANGIO-PRESS LITE DVT Compression Device has been compared with "ANGIO-PRESS DVT Compression Device Model Name: IPCS". The subject device has same intended use, principle of operation and similar technological characteristics as the predicate device. Although there are some specifications that are different between two devices, the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.
5.12 Conclusion
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the ANGIO-PRESS LITE DVT 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).