(233 days)
- To help prevent Deep Vein Thrombosis (DVT)
The Flowtron Small Calf Garment is a wraparound Calf garment comprising of a bladder and surrounding material intended to apply cyclic compression to calf to improve return venous blood flow to prevent and reduce the risk of Deep Vein Thrombosis (DVT). The Flowtron Small Calf Garment is connected to an ArjoHuntleigh Flowtron pneumatic pump. The pump controls and generated the delivery of air to inflate and deflate the Calf Garment in a cyclic manner. Flowtron Calf Garments are configured with a custom design connector that means that they are only compatible with ArjoHuntleigh Flowtron pneumatic pumps
This document, K172103, is a 510(k) premarket notification for a medical device called the Flowtron DVT5 Small Calf Garment, manufactured by Getinge (Suzhou) Co., Ltd. and ArjoHuntleigh.
Based on the provided text, this K172103 document is not about an AI/ML-driven medical device. Instead, it concerns a physical medical device (a compressible limb sleeve) used to prevent Deep Vein Thrombosis (DVT). The "acceptance criteria" and "study" described in the document relate to the physical and functional performance of this device and its substantial equivalence to a predicate device, not to the performance of an AI algorithm.
Therefore, many of the requested points regarding AI/ML device evaluation criteria (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training ground truth) are not applicable to this specific document as it does not describe an AI medical device.
However, I can extract and structure the relevant "acceptance criteria" and "study" information pertinent to this physical device as described in the document.
Here's the information derived from the provided text, with emphasis on what is available and a clear indication of what is not applicable due to the nature of the device:
Device Name: Flowtron DVT5 Small Calf Garment
Regulation Name: Compressible Limb Sleeve
Regulatory Class: Class II
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of quantitative acceptance criteria with numerical performance targets. Instead, it describes various performance tests conducted to demonstrate substantial equivalence to a predicate device (K925717, DVT10(S) Limb Compression Sleeves Calf Garments). The "acceptance criteria" can be inferred as "Passed" for each test, indicating that the device met the required performance for equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance testing of garments – Pressure cyclic test with Flowtron pneumatic pumps conducted successfully | Passed |
| Durability of garment fastening evaluated successfully | Passed |
| Evaluation at environmental extremes conducted successfully | Passed |
| Evaluation of shelf life conducted successfully | Passed |
| Evaluation of shipping and distribution conducted successfully | Passed |
| Evaluation of biocompatibility conducted successfully | Passed |
Note: The core "acceptance criteria" here is that the new device (DVT5) is "identical in materials, function and indications for use" to the predicate device (DVT10(S)), with the only difference being size. The testing aims to prove that this size difference does not negatively impact performance or safety, thus maintaining substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. The document refers to "testing to demonstrate equivalence" but does not quantify the number of units tested.
- Data Provenance: Not explicitly stated. The manufacturer is Getinge (Suzhou) Co., Ltd. in China, but the location where the testing was conducted is not specified. The studies appear to be part of the premarket notification, implying they are new studies conducted for this submission (prospective in that sense) rather than retrospective analysis of existing data.
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)
- Not Applicable. This is a physical device, and the "ground truth" for its performance is based on engineering and materials testing, not expert interpretation of diagnostic images or data. No human experts are described as establishing "ground truth" in the way an AI/ML study would require.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No human adjudication process is described for the performance tests of this physical device.
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
- Not Applicable. This is not an AI/ML device, and no human reader studies or MRMC studies are described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device, and therefore, no algorithm-only performance study was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering and physical performance specifications (e.g., pressure cycles, durability, environmental stability, biocompatibility, shelf-life, shipping resilience) compared to the predicate device. These are objective measures determined through laboratory testing, not medical consensus or patient outcomes directly.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As no training set exists for this type of device, this question is irrelevant.
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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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
March 2, 2018
Getinge (Suzhou) Co., Ltd. % David Movnham Regulatory Compliance Manager ArjoHuntleigh AB 35 Portmanmoor Road Cardiff, cf24 5hn Gb
Re: K172103
Trade/Device Name: Flowtron DVT5 Small Calf Garment Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: January 10, 2018 Received: January 19, 2018
Dear David Moynham:
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
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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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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Image /page/2/Picture/0 description: The image shows the logo for ArjoHuntleigh, a Getinge Group company. The text "ARJOHUNTLEIGH" is displayed in two colors, with "ARJO" in blue and "HUNTLEIGH" in gray. Below the company name, the text "GETINGE GROUP" is written in gray, indicating that ArjoHuntleigh is part of the Getinge Group.
Indications For Use
510(k) Number: K172103
Device Name: Flowtron DVT5 Small Calf Garment
Indications for Use:
- . To help prevent Deep Vein Thrombosis (DVT)
Prescription Use YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Summary Flowtron DVT5 Small Calf Garments
ARJOHUNTLEIGH
GETINGE GROUP
K172103 page 1 of 2
| Name & Address: | Getinge (Suzhou) Co., Ltd.No. 158 Fangzhou RoadSip, Suzhou, Jiangsu,Suzhou Jiangsu, CHINA 215024 | ||
|---|---|---|---|
| Telephone: | +(44) 29 2044 7084 | ||
| Fax: | +(44) 29 2049 2520 | ||
| Prepared: | 01 December 2017 | ||
| Contact: | David Moynham – Regulatory Compliance Manager | ||
| Device Name: | Flowtron DVT5 Small Calf Garment | ||
| Common Name | Sleeve, Limb, Compressible | ||
| Classification | Class | Product Code | Classification Regulation |
| II | JOW | 21 CFR 870.5800 | |
| Classification Name: | Sleeve, Limb, Compressible | ||
| Predicate Device: | K925717, DVT10(S) Limb Compression Sleeves Calf Garments | ||
| Indications for Use: | • To help prevent Deep Vein Thrombosis (DVT) | ||
| Description : | The Flowtron Small Calf Garment is a wraparound Calf garmentcomprising of a bladder and surrounding material intended to applycyclic compression to calf to improve return venous blood flow toprevent and reduce the risk of Deep Vein Thrombosis (DVT). | ||
| The Flowtron Small Calf Garment is connected to an ArjoHuntleighFlowtron pneumatic pump. The pump controls and generated thedelivery of air to inflate and deflate the Calf Garment in a cyclicmanner. | |||
| Flowtron Calf Garments are configured with a custom design connectorthat means that they are only compatible with ArjoHuntleigh Flowtronpneumatic pumps |
Models
| Model REF | Device | Feature |
|---|---|---|
| DVT5 | Flowtron Small Calf Garment Up to 36 cm (14") | Smaller Size |
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Image /page/4/Picture/0 description: The image contains the logo for ARJOHUNTLEIGH GETINGE GROUP. The text "ARJOHUNTLEIGH" is displayed in two colors, with "ARJO" in blue and "HUNTLEIGH" in gray. Below this, the words "GETINGE GROUP" are written in gray, indicating that ArjoHuntleigh is part of the Getinge Group.
Substantial Equivalence: The Flowtron DVT5 Small Calf Garment and the DVT10(S) Calf Garment included in the predicate device clearance are identical in materials, function and indications for use.
The only difference being the size of the Flowtron Calf Garment.
Full details of the verification and validation of the smaller calf garments have been included in the submission.
Testing to demonstrate equivalence included:
| Testing conducted | Result |
|---|---|
| Performance testing of garments – Pressure cyclictest with Flowtron pneumatic pumps. | Passed |
| Evaluation of durability of garment fastening. | Passed |
| Evaluation at environmental extremes. | Passed |
| Evaluation of shelf life | Passed |
| Evaluation of shipping and distribution | Passed |
| Evaluation of biocompatibility | Passed |
Technologies Summary: DVT garments are compression sleeves intended to be wrapped around patient calf. They inflate and deflate in a cyclic manner when connected to a Flowtron pneumatic pump. The garments are passive devices and do not contain any technologies. The Flowtron pneumatic pump is the active part of the system but is outside the scope of this application. The subject garment DVT5 is non-sterile and the predicate device is sterile. The differences in garments are the size aspect. The difference being
the size from DVT10(S) (Sleeves are extended in width, so that are suitable to fit a patient's calf of up to 17 inches circumference) to that of DVT5 (Small garment designed to fit calf circumferences up to 14inches).
Conclusion: The submission device and the predicate device are identical in in materials, function and indications for use.
The differences are the width and the height of the submission device.
The data detailed within submission including that drawn from the nonclinical tests demonstrate that the predicate and the submission device are substantially equivalent.
§ 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).