(231 days)
SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.
Compression Sleeves are inflatable cuffs designed to apply intermittent pressure to the foot, calf or thigh in order to increase venous return and prevent pooling of blood associated with the formation of Deep Vein Thrombosis (DVT). The devices consist of inflatable vinyl bladder(s) lined with an outer non-woven fabric; the bladder is connected to pneumatic tubing for connection with a compatible pump system that controls the sleeve's pressure cycle. Hook-and-loop fasteners sewn into the fabric are used to secure the sleeve to the foot or leg. Models are available in a range of dimensions in order to fit varying foot, calf and thigh circumferences. Reprocessed sleeves have identical technological characteristics as the predicate devices, i.e. device materials, dimensions, operating principle and system compatibility are unchanged during reprocessing. SureTek sleeves are provided as sterile, while the manufacturer product is provided non-sterile.
The SureTek Reprocessed Compression Sleeve is a medical device intended to increase venous return as a prophylaxis to Deep Vein Thrombosis (DVT) by applying intermittent pressure to the lower extremities. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The device is a reprocessed compression sleeve, and as such, its performance criteria are primarily focused on demonstrating equivalence to new, unused devices and compliance with relevant reprocessing and sterility standards.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Performance substantially equivalent to new, unused devices | Bench testing following the maximum number of use and reprocessing cycles found their performance to be substantially equivalent to new, unused devices. |
| Cleaning Efficacy | Effective decontamination of grossly contaminated instruments | SureTek cleaning process is validated to be effective for decontamination of grossly contaminated instruments under worst-case operational conditions. |
| Packaging Integrity & Sterility Maintenance | Conforms to ISO 11607 (packaging for terminally sterilized medical devices) and relevant EN868-1, ASTM standards. Maintenance of product sterility. | Product packaging conforms to all relevant requirements of ISO 11607, with performance qualifications tested according to EN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02. Product sterility and process validation conform to the relevant requirements of ISO 11135 Medical Devices – Validation and routine control of ethylene oxide sterilization. |
| Biocompatibility & Safety | Conforms to ISO 10993 (biological evaluation of medical devices for ethylene oxide residuals and biocompatibility) | Products conform to the relevant requirements of ISO 10993 Biological Evaluation of Medical Devices for ethylene oxide residuals and biocompatibility of device materials. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Bench Testing: The document states "maximum number of use and reprocessing cycles." A specific number of devices or cycles is not provided in the summary.
- Data Provenance: The studies described (bench testing, cleaning validation, packaging, sterility, and biocompatibility testing) are all prospective tests performed on the reprocessed devices themselves. The country of origin of the data is not specified, but it can be inferred that the testing was conducted to meet US regulatory requirements.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This type of device (a reprocessed compression sleeve) does not typically involve human expert interpretation for "ground truth" establishment in the same way an AI diagnostic algorithm would. The listed studies are technical validations against established standards. Therefore, information about the number or qualifications of "experts" to establish a diagnostic ground truth is not applicable or provided. The "truth" is determined by measurements against engineering and biological standards.
4. Adjudication Method for the Test Set
Not applicable. The studies conducted are not based on expert adjudication of cases, but rather on direct measurements and validations against standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a reprocessed medical device, not an AI-assisted diagnostic tool. Therefore, a MRMC comparative effectiveness study involving human readers improving with AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a physical medical device (a reprocessed compression sleeve), not a standalone algorithm.
7. Type of Ground Truth Used
The ground truth used for proving acceptance was based on a combination of:
- Performance Standards: Comparisons to the performance characteristics of new, unused predicate devices.
- Validated Test Methods and Industry Standards: Compliance with international standards such as ISO 11607, EN868-1, ASTM F88-00, F2906-04, D4169-04a, F1980-02, ISO 11135, and ISO 10993.
- Worst-Case Scenario Validation: Specific validation of cleaning efficacy under "worst case operational conditions."
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI algorithm, there is no training set or associated ground truth establishment process in that context.
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K052691
MAY 17 2006
· ·
SureTek Medical 510(k) Summary
| Submitter | SureTek Medical | 25-B Maple Creek Circle Greenville, SC 29607 | |
|---|---|---|---|
| Contact | Mike Sammon, Ph.D. | 864-299-9743 | |
| Date | 9/25/05 | ||
| Product | SureTek Reprocessed Compression Sleeve | ||
| Classification | Code:JOW Regulation: 21 CFR 870.5800 Name: Compressible Limb Sleeve | ||
| PredicateDevices | Manufacturer/Reprocessor | Tradename(s) | 510(k)'s |
| Huntleigh Healthcare | Flowtron* | K022786, K010744 | |
| Kendall (Tyco Healthcare) | SCD*, Impad* | K992079, K964425 | |
| Kinetic Concepts | Plexipulse* | K981311 | |
| Compression Therapy | VasoPress* | K003828 | |
| Currie Medical | Alternating Leg Pressure, ALP* | K000303 | |
| Aircast | Venaflow* | K992454, K023800 | |
| Alba Health | pulStar* | K961405 | |
| SterilMed | Reprocessed Compression Sleeves | K012597 | |
| Vanguard Medical Concepts | Reprocessed Compression Garment | K012403 | |
| DeviceDesign andDescription | Compression Sleeves are inflatable cuffs designed to apply intermittent pressure to the foot, calfor thigh in order to increase venous return and prevent pooling of blood associated with theformation of Deep Vein Thrombosis (DVT). The devices consist of inflatable vinyl bladder(s)lined with an outer non-woven fabric; the bladder is connected to pneumatic tubing for connectionwith a compatible pump system that controls the sleeve's pressure cycle. Hook-and-loopfasteners sewn into the fabric are used to secure the sleeve to the foot or leg. Models are availablein a range of dimensions in order to fit varying foot, calf and thigh circumferences. Reprocessedsleeves have identical technological characteristics as the predicate devices, i.e. device materials,dimensions, operating principle and system compatibility are unchanged during reprocessing.SureTek sleeves are provided as sterile, while the manufacturer product is provided non-sterile. | ||
| Intended Use | SureTek Compression Sleeves are intended for use with a compatible pump controller forintermittent compression of the lower extremities so as to increase venous return as a prophylaxisto Deep Vein Thrombosis. | ||
| Testing andStandards | • Bench testing of devices following the maximum number of use and reprocessing cycles foundtheir performance to be substantially equivalent to new, unused devices.• SureTek cleaning process is validated to be effective for decontamination of grosslycontaminated instruments under worst case operational conditions.• Product packaging conforms to all relevant requirements of ISO 11607 Packaging forterminally sterilized medical devices, with performance qualifications tested according toEN868-1 and ASTM F88-00, F2906-04, D4169-04a and F1980-02.• Product sterility and process validation conform to the relevant requirements of ISO 11135Medical Devices – Validation and routine control of ethylene oxide sterilization.• Products conform to the relevant requirements of ISO 10993 Biological Evaluation of MedicalDevices for ethylene oxide residuals and biocompatibility of device materials.. | ||
| SubstantialEquivalence | Product testing and comparisons of specifications determines that SureTek ReprocessedCompression Sleeves are substantially equivalent to their predicate devices with respect to deviceintended use and performance, as well as product packaging, labeling and safety. |
* The listed product tradenames are registered trademarks of their respective manufacturers.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 17 2006
SureTek Medical c/o Mike Sammon, Ph.D. CEO President 44 Bellwood Farms Greenville, SC 29607
Re: K052691
SureTek Reprocessed Compression Sleeve Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: April 1, 2006 Received: April 5, 2006
Dear Dr. Sammon:
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.
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 - Mike Sammon, Ph.D.
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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Dunia R. Vochner
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): _K052691
Device Name: SureTek Reprocessed Compression Sleeve
| Manufacturer | Model Number | Manufacturer | Model Number |
|---|---|---|---|
| Huntleigh | DVT10 | Compression Therapy | VP 501M |
| Huntleigh | DVT20 | Compression Therapy | VP 501L |
| Huntleigh | DVT60 | Compression Therapy | VP 501B |
| Huntleigh | DVT30 | Compression Therapy | VP 530M |
| Huntleigh | DVT40 | Compression Therapy | VP 530L |
| Huntleigh | FG100 | Compression Therapy | VP 520 |
| Huntleigh | FG200 | Currie Medical | ALP 1 |
| Kendall | 5329 | Currie Medical | ALP 2 |
| Kendall | 5489 | Currie Medical | ALP 5 |
| Kendall | 5345 | Currie Medical | ALP 3 |
| Kendall | 5330 | Currie Medical | ALP 4 |
| Kendall | 5480 | Currie Medical | PVA 1 |
| Kendall | 5065 | Currie Medical | PVA 2 |
| Kendall | 5075 | Aircast | 3010 |
| Kinetic Concepts | 28900000 | Aircast | 3012 |
| Kinetic Concepts | 28900001 | Aircast | 3014 |
| Alba Healthcare | 51558-01 | Aircast | 3015 |
| Alba Healthcare | 51558-02 | Aircast | 3016 |
Indications for Use: SureTek Compression Sleeves are intended for use with a compatible pump controller for intermittent compression of the lower extremities so as to increase venous return as a prophylaxis to Deep Vein Thrombosis.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Vockner
II Sign-Siovascular Device
510(k) number K052691
§ 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).