(28 days)
The DVT60 Compression Sleeve is designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow.
The DVT60 Compression Sleeves are single chamber inflatable cuffs, designed to fit around a patient's calf. They are used with the Huntleigh Flowtron Excel and Universal Pumps. When inflated, they compress the veins in the calf and expel blood out of the leg, promoting circulation and overcoming stasis.
Here's an analysis of the provided text regarding the DVT60 Limb Compression Sleeves, focusing on acceptance criteria and the supporting study:
The provided text does not contain a traditional set of acceptance criteria with quantitative metrics or a detailed study report comparing the DVT60 against specific, pre-defined performance thresholds. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Huntleigh Healthcare DVT10) through functional equivalence in inflation performance.
Here's a breakdown of the requested information based on the provided text, with clarifications where the information is not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) submission, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device. The "reported device performance" is a comparative statement.
| Acceptance Criteria (Implied by Equivalence to Predicate) | Reported DVT60 Device Performance |
|---|---|
| Technological Characteristics: | |
| - Design characteristics are the same. | - Design characteristics are the same as the DVT10 predicate device. |
| - Materials are the same. | - Materials are the same as the DVT10 predicate device. |
| - Method of manufacture is the same. | - Method of manufacture is the same as the DVT10 predicate device. |
| - Inflation sequence and pressures are the same. | - Inflation sequence and pressures are the same as the DVT10 predicate device. |
| Functional Equivalence (Inflation Performance Testing): | |
| - Venous blood velocity increase is similar to predicate. | - Venous blood velocity increase is similar to the DVT10 predicate device. |
| - Duration of increased venous blood velocity is similar to predicate. | - Duration of increased venous blood velocity is similar to the DVT10 predicate device. |
| - Ability to overcome venous stasis (prevents DVT). | - Helps to prevent deep vein thrombosis by increasing blood velocity and overcoming venous stasis, in the same manner as the DVT10 predicate device. |
| Intended Use: | |
| - Prevent Deep Vein Thrombosis (DVT) by increasing venous blood flow. | - Designed to help prevent Deep Vein Thrombosis (DVT), by increasing venous blood flow (same as predicate). |
| Dimensions: | - Extended in width (compared to DVT10) to fit a patient's calf up to 28 inches circumference. (This is a difference from the predicate, but deemed acceptable within the scope of intended use and effectiveness, likely because fitting a wider range of patients is a benefit and doesn't negatively impact the core function). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states, "The sleeves are tested by fitting to a subject's calf..." This implies at least one subject, but a specific number is not provided. This is common for this type of equivalence testing which might involve a small number of healthy volunteers for physiological measurements.
- Data Provenance: Not explicitly stated in terms of country of origin. The testing is described as "non-clinical outcome, inflation performance testing," which strongly suggests a prospective study (i.e., conducted specifically for this submission).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable/not mentioned. Ground truth in this context isn't established by expert consensus on clinical images or diagnoses. Instead, the "ground truth" (or performance measure) is the physiological measurement of blood flow velocity.
- Qualifications of Experts: Not applicable/not mentioned. The testing involves measuring a physiological parameter rather than expert interpretation.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not mentioned. Since the performance metric is a direct physiological measurement (blood flow velocity), expert adjudication of results, in the sense of resolving discrepancies between multiple expert opinions, is not relevant. The measurements would be taken by trained personnel using appropriate equipment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done.
- The device is a limb compression sleeve, not an imaging or diagnostic AI device that would typically involve human reader performance. The evaluation focuses on the physiological effect of the device on blood flow.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This is a physical medical device (compression sleeve), not a software algorithm. Its "performance" is its mechanical action and physiological effect on the human body.
7. Type of Ground Truth Used
- Physiological Measurement Data: The "ground truth" for the test set is established by direct physiological measurement of "the increase in velocity of the blood flow in the veins during compression" on "a subject's calf."
8. Sample Size for the Training Set
- Not applicable. This device does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for this device, this question is not relevant.
In summary: The K022786 submission for the DVT60 Limb Compression Sleeves relies on demonstrating substantial equivalence to a predicate device (DVT10) through non-clinical functional performance testing. The "study" involves measuring physiological blood flow velocity increase in subjects wearing the sleeves and confirming its similarity to the predicate device. This is a common approach for Class II devices where a direct comparison to a previously cleared device's functionality is sufficient to establish safety and effectiveness.
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510(k) SUMMARY DVT60 Limb Compression Sleeves
| Company | Huntleigh Healthcare Inc40 Christopher WayEatontownNew Jersey | |
|---|---|---|
| Contact | Audrey WitkoPhoneFax | 732 578 9898732 460 5809 |
| SummaryPreparation Date | 1ST August 2002 | |
| Trade Name | DVT60 | |
| Common Name | Limb Compression Sleeves | |
| Classification Name | Sleeve, Limb, Compression (JOW) | |
| Predicate Device | Huntleigh Healthcare DVT10(s) K925717/A | |
| Device Description | The DVT60 Compression Sleeves are single chamberinflatable cuffs, designed to fit around a patient'scalf.They are used with the Huntleigh Flowtron Excel andUniversal Pumps.When inflated, they compress the veins in the calfand expel blood out of the leg, promoting circulationand overcoming stasis. | |
| Intended Use | DVT60 sleeves are designed to help prevent DeepVein Thrombosis (DVT), by increasing venous bloodflow. | |
| Summary of Technological Characteristics |
SEP 1 9 2002
The DVT60 compression sleeves have the same technological characteristics as the DVT10 predicate device.
The design characteristics, materials, and method of manufacture are the same,
When compared to the predicate device, the DVT60 sleeves are extended in width, so that are suitable to fit a patient's calf of up to 28 inches circumference.
HEALTH
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Determination of Substantial Equivalence
The determination of Substantial Equivalence is based on non-clinical outcome, inflation performance testing. The sleeves are tested by fitting to a subject's calf and observing the increase in velocity of the blood flow in the veins during compression.
Equivalence Testing Results
The sleeves are made from similar materials and compress a similar area of the patient's limb. The inflation sequence and pressures are the same.
The venous blood velocity increase and duration are similar to the predicate device. This increase in blood velocity overcomes venous stasis and so helps to prevent deep vein thrombosis, in the same manner as the predicate device.
Therefore, we propose that the clinical treatment that the patient receives will be equivalent.
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Public Health Service
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The eagle is enclosed within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 9 2002
Huntleigh Healthcare, Inc. c/o Ms. Audrey Witko Vice President. Corporate & Clinical Affairs 40 Christopher Way Eatontown, NJ 07724
Re: K022786 Trade Name: DVT60 Regulation Number: 21 CFR 870.5800 Regulation Name: Sleeve, Limb, Compression Regulatory Class: Class II (two) Product Code: JOW Dated: May 23, 2002 Received: August 22, 2002
Dear Ms. Witko:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Audrey Witko
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
V. Prem D. Zuckerman, M.D.
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 STATEMENT DVT60 Limb Compression Sleeves
Ver/3-4/24/96
| Applicant: | Huntleigh Healthcare Inc. |
|---|---|
| 510(k) Number (if known): | Not known at present |
| Device Name: | DVT60 |
| Indications For Use: |
The DVT60 Compression Sleeve is designed to help prevent Deep Vein
Thrombosis (DVT), by increasing venous blood flow.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | |
|---|---|
| ------------------------------------------ | ------------------------------------------------------- |
Division of Cardiovascular & Respiratory Devices
| 510(k) Number | K022786 |
|---|---|
| --------------- | --------- |
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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).