(127 days)
No
The summary describes a mechanical compression garment and its reprocessing method. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to be used as a non-invasive therapeutic method to help prevent Deep Vein Thrombosis (DVT) and resulting pulmonary embolism."
No
The device is a therapeutic method to prevent Deep Vein Thrombosis (DVT) by applying pressure to the limb, not a diagnostic tool.
No
The device description clearly states it is a "compression garment" constructed with a "three-chamber bladder enclosed in a polyester garment," which are physical hardware components. The 510(k) summary focuses on the reprocessing of this physical garment and its functional testing.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "help prevent Deep Vein Thrombosis (DVT) and resulting pulmonary embolism" through a non-invasive therapeutic method (compression). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a compression garment that applies pressure to a limb. This is a physical therapy device, not a device used to analyze biological samples.
- No mention of in vitro testing: The description focuses on the mechanical function of the garment and the reprocessing method (thermal disinfection). There is no mention of analyzing blood, urine, tissue, or any other sample taken from the patient.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The RENU Medical Reprocessed Tri Pulse Compression Garment are to be used as a non-invasive therapeutic method to help prevent Deep Vein Thrombosis (DVT) and resulting pulmonary embolism.
Product codes (comma separated list FDA assigned to the subject device)
JOW
Device Description
The Reprocessed Tri Pulse Compression Garment is a compression garment that is attached to a patient's limb. It is designed to work with the Arjo Flowtron ACS800 Pump and Arjo Flowtron ACS900 Pump only. Each garment is compressed alternately, applying pressure to the patient's limb, to help prevent deep vein thrombosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's limb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The bench tested done on the devices was Cycle Verification Testing. This test examines the effect of the ReNu reprocessing system on the durability and functionality of the devices. The purpose of this test is to ensure that the Tri-Pulse Compression Garments can withstand the thermal temperatures that they're subject to during a reprocessing hot water pasteurization cycle.
During this test, a sample of devices were reprocessed 10 times each and subject to functional testing after each individual cycle in order to ensure that each device meets its functional requirements.
Each device was subject to a pasteurization cycle, then placed around PVC to simulate a patient use. Once situated, it was pumped up by an OEM pump and pressure readings were taken to ensure that the compression garment met its pressure and inflation time requirements and repeated until the Reprocessed Compression Garment met its cycle limit. This verification report, document ID #12915, titled, Cycle Verification Report, TRP DVT, can be found in section 18.4, Supporting Documents.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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May 7, 2021
RENU Medical, Inc Darren DeMerritt Director RA/OA 830 80th ST SW Suite 100 Everett, Washington 98203
Re: K203847
Trade/Device Name: Reprocessed Tri Pulse Compression Garment Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible limb sleeve Regulatory Class: Class II Product Code: JOW Dated: April 8, 2021 Received: April 9, 2021
Dear Darren DeMerritt:
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. 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 located 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.
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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 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,
for Nicole Gillette Assistant Director (Acting) 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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The item numbers included in the scope of this 510(k) submission are as follows:
| Item No | Sleeve Description |
|---|---|
| RM-TRP10 | Flowtron Regular Sequential Calf Garment |
| RM-TRP20 | Flowtron Large Sequential Calf Garment |
| RM-TRP30 | Flowtron Regular Sequential Thigh Garment |
| RM-TRP40 | Flowtron Large Sequential Thigh Garment |
| RM-TRP60L | Flowtron Bariatric Sequential Calf Garment |
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Indications for Use
510(k) Number (if known)
Device Name
Reprocessed Tri Pulse Compression Garments
Indications for Use (Describe)
The RENU Medical Reprocessed Tri Pulse Compression Garment are to be used as a non-invasive therapeutic method to help prevent Deep Vein Thrombosis (DVT) and resulting pulmonary embolism.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
[X] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
Reprocessed Tri Pulse Compression Garments
| Name & Address: | RENU Medical, Inc.
830 80th ST SW Suite 100
Everett, WA 98203 |
|-----------------|---------------------------------------------------------------------|
| Telephone: | 425-353-1110 |
| Fax: | 425-353-9116 |
| Prepared: | December 29, 2020 |
| Contact: | Darren DeMerritt, Director RA/QA |
| Device Name: | Reprocessed Tri Pulse Compression Garment |
| Common Name: | Compressible Limb Sleeve |
Classification
| Class | Product | Classification | ||
|---|---|---|---|---|
| Code | Regulation | |||
| ll | JOW | 21 CFR 870.5800 | ||
| Classification Name: | Sleeve, Limb, Compressible | |||
| Predicate Devices: | 12, 2003 (K031559). | RENU Medical Reprocessed Compressible Limb Sleeves, cleared November | ||
| Arjo Huntleigh (K133119). | The following is a reference device: | Tri Pulse Garments cleared February 28, 2014, originally manufactured by | ||
| Indications for Use: | The RENU Medical Reprocessed Tri Pulse Compression Garment are to be | |||
| used as a non-invasive therapeutic method to help prevent Deep Vein | ||||
| Thrombosis (DVT) and resulting pulmonary embolism. | ||||
| Description: | The Reprocessed Tri Pulse Compression Garment is a compression garment | |||
| that is attached to a patient's limb. It is designed to work with the Arjo | ||||
| Flowtron ACS800 Pump and Arjo Flowtron ACS900 Pump only. Each | ||||
| garment is compressed alternately, applying pressure to the patient's limb, | ||||
| to help prevent deep vein thrombosis. |
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Models:
| Model ID: | Device | Features |
|---|---|---|
| TRP10, TRP20, | ||
| TRP30, TRP40 | ||
| and TRP60 | Tri Pulse Compression | |
| Garment | Sequential inflation providing active | |
| compression. |
| Substantial Equivalence: | The equivalence of the Tri Pulse garments is demonstrated using
bench testing to determine that the reprocessing methods do not
adversely affect the device from performing to the specifications
outlined by the OEM predicate device (K133119). |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The bench tested done on the devices was Cycle Verification Testing. This
test examines the effect of the ReNu reprocessing system on the
durability and functionality of the devices. The purpose of this test is to
ensure that the Tri-Pulse Compression Garments can withstand the
thermal temperatures that they're subject to during a reprocessing hot
water pasteurization cycle. |
| | During this test, a sample of devices were reprocessed 10 times each and
subject to functional testing after each individual cycle in order to ensure
that each device meets its functional requirements. |
| | Each device was subject to a pasteurization cycle, then placed around
PVC to simulate a patient use. Once situated, it was pumped up by an
OEM pump and pressure readings were taken to ensure that the
compression garment met its pressure and inflation time requirements
and repeated until the Reprocessed Compression Garment met its cycle
limit. This verification report, document ID #12915, titled, Cycle
Verification Report, TRP DVT, can be found in section 18.4, Supporting
Documents. |
| | Additionally, the Reprocessed Tri Pulse Garments are substantially
equivalent to other reprocessed compression garments and
therefore are able to achieve the same cycle limits of other
previously cleared reprocessed compression garments (K031559). |
| Technologies Summary: | Tri Pulse garments are constructed with a three-chamber bladder
enclosed in a polyester garment, which is wrapped around the limb
and secured with hook and eye tabs. When connected to the pump, |
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the garment inflates through a single connecting tube to generate a sequential compression effect on the limb.
Reprocessing the Tri-Pulse Compression Garment is conducted by achieving high-level disinfection via thermal disinfection methods. This process is conducted by holding the devices at or above a predetermined specified temperature for a predetermined specified duration.
Conclusion: The data detailed within submission demonstrates that the device is as safe and effective as the predicate and performs as well as the legally marketed predicate devices, identified in this summary.