(28 days)
Reprocessed SCD™ Express Compression Sleeves (Large and X-Large Sizes) & Reprocessed SCD™ Comfort Compression Sleeves (All Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
Reprocessed SCD™ Express Compression Sleeves (Small and Medium Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
The Reprocessed Compression Sleeves are the sleeve component of the pneumatic compression system intended to apply circumferential pressure to a patient's leg. This pressure will aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The Reprocessed Compression Sleeves are compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubing to individual bladders within the sleeve. The controller delivers and monitors the pressure within the bladders. Once predetermined time and pressure criteria are met, the pressure is released by venting air through a valve system.
The Reprocessed Compression Sleeves are for single-patient-use and are available in knee length (both Express and Comfort Sleeves) and thigh length (Express Sleeves only) configurations.
This document describes the reprocessing of Kendall SCD Express Compression Sleeves and Kendall SCD Comfort Compression Sleeves. The information provided heavily focuses on the equivalence of the reprocessed devices to previously reprocessed devices and the original equipment manufacturer (OEM) devices, rather than a study proving the device meets specific performance acceptance criteria for a new medical device.
Therefore, many of the specific questions about "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of a diagnostic or AI device, for example, are not directly applicable to this submission. The "study" mentioned here is primarily bench-top verification and cleaning validation to demonstrate that the reprocessed sleeves maintain appropriate functional characteristics and are substantially equivalent.
Here's an attempt to answer the questions based on the provided text, acknowledging the limitations:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of discrete acceptance criteria with specific numerical thresholds for performance (e.g., sensitivity, specificity, accuracy) like one would expect for a diagnostic device. Instead, the acceptance criteria are implicitly met by demonstrating "appropriate functional characteristics" and "substantial equivalence" through the following:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Visual Inspection | Passed (part of internal manufacturing process prior to release) |
| Simulated Use Testing | Passed (demonstrates appropriate functional characteristics) |
| Leak Testing | Passed (demonstrates appropriate functional characteristics) |
| System Compatibility Verification | Passed (demonstrates appropriate functional characteristics with OEM controller) |
| Cleaning Validation | Passed (demonstrates safety and cleanliness after reprocessing) |
| Functional Testing (post-reprocessing) | Passed (demonstrates all reprocessed products meet functional requirements prior to release) |
| Substantial Equivalence to Predicate Device (K161105) | Achieved (based on cleaning validation and functional testing) |
| Maintenance of Intended Use | Confirmed (no changes to clinical applications, patient population, performance specifications, or method of operation) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "Representative samples of the Reprocessed Compression Sleeves were tested." However, it does not specify the exact sample size used for the bench-top verification, simulated use, leak testing, system compatibility verification, or cleaning validation.
- Data Provenance: The document implies the testing was conducted by Covidien, a US-based company (Mansfield, MA). The data would be prospective in that the tests were carried out specifically for this 510(k) submission on samples.
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)
This question is not applicable to this submission. "Ground truth" in the context of expert consensus (like for AI or diagnostic devices) is not relevant here. The ground truth for this device lies in its physical functionality, safety (cleaning), and equivalence to the predicate, which would be assessed by engineers/technicians and regulatory review against established standards and internal specifications, not expert diagnostic interpretation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or studies involving subjective interpretation (e.g., by multiple readers) to resolve discrepancies and establish a robust ground truth. Here, the tests are objective bench-top measurements and validations.
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 question is not applicable. The device is a reprocessed compression sleeve, not a diagnostic or AI-powered system that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device, not an algorithm.
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 specifications and standards: The performance metrics (e.g., pressure output, leak integrity, compatibility) are compared against pre-defined engineering requirements for the device type.
- Predicate device performance: The reprocessed device's performance is expected to be identical to the predicate device in functional characteristics.
- Cleaning validation standards: To ensure the device is safe and effectively reprocessed.
8. The sample size for the training set
This question is not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this type of device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 19, 2017
Covidien Nicole Genco Senior Regulatory Affairs Specialist 15 Hampshire Street Mansfield, Massachusetts 02048
Re: K163620
Trade/Device Name: Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves Regulation Number: 21 CFR 870.5800 Regulation Name: Compressible Limb Sleeve Regulatory Class: Class II Product Code: JOW Dated: December 21, 2016 Received: December 22, 2016
Dear Nicole Genco:
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 (reporting of medical device
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related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Hillebrand
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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| Reprocessed Single-Use Device Models Included in Clearance: | ||||
|---|---|---|---|---|
| -- | -- | ------------------------------------------------------------- | -- | -- |
| Device Model | Device Name | OriginalManufacturer |
|---|---|---|
| 9529R | Reprocessed Express Sleeve – Knee LengthMedium | Covidien |
| 9789R | Reprocessed Express Sleeve – Knee LengthLarge | Covidien |
| 9790R | Reprocessed Express Sleeve – Knee Length X-Large | Covidien |
| 9545R | Reprocessed Express Sleeve – Thigh LengthSmall | Covidien |
| 9530R | Reprocessed Express Sleeve – Thigh LengthMedium | Covidien |
| 9780R | Reprocessed Express Sleeve – Thigh LengthLarge | Covidien |
| 74021R | Reprocessed Comfort Sleeve – Knee LengthSmall | Covidien |
| 74022R | Reprocessed Comfort Sleeve – Knee LengthMedium | Covidien |
| 74023R | Reprocessed Comfort Sleeve – Knee LengthLarge | Covidien |
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Indications for Use
510(k) Number (if known)
Device Name
Reprocessed SCD™ Express Compression Sleeves Reprocessed SCD™Comfort Compression Sleeves
Indications for Use (Describe)
Reprocessed SCD™ Express Compression Sleeves (Large and X-Large Sizes) & Reprocessed SCD™ Comfort Compression Sleeves (All Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
Reprocessed SCD™ Express Compression Sleeves (Small and Medium Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in at-risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a white rectangle in the center and a light blue vertical line running through the middle. To the right of the square is the word "COVIDIEN" in blue, sans-serif font.
510(K) SUMMARY
1. 510(k) Owner:
Covidien 15 Hampshire Street Mansfield, MA 02048
| Contact: | Nicole Genco |
|---|---|
| Title: | Senior Regulatory Affairs Specialist |
| Telephone: | (508) 452-4128 |
| Date Prepared: | December 21, 2016 |
2. Device:
| Trade Names: | Reprocessed SCD™ Express Compression SleeveReprocessed SCD™ Comfort Compression Sleeve |
|---|---|
| Common Name: | Reprocessed Compression Sleeve |
| Classification Name: | Sleeve, Limb, Compressible |
| Regulation Number: | 21 CFR 870.5800 |
| Product Code: | JOW |
| Classification: | Class II |
3. Predicate Devices:
Covidien Reprocessed Compression Garments (K161105)
4. Device Description:
The Reprocessed Compression Sleeves are the sleeve component of the pneumatic compression system intended to apply circumferential pressure to a patient's leg. This pressure will aid in the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE).
The Reprocessed Compression Sleeves are compatible with the OEM pneumatic compression controller. The controller generates air pressure which is transferred through tubing to individual bladders within the sleeve. The controller delivers and monitors the pressure within the bladders. Once predetermined time and pressure criteria are met, the pressure is released by venting air through a valve system.
The Reprocessed Compression Sleeves are for single-patient-use and are available in knee length (both Express and Comfort Sleeves) and thigh length (Express Sleeves only) configurations.
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5. Indications for Use:
Reprocessed SCD™ Express Compression Sleeves (Large and X-Large Sizes) & Reprocessed SCD™ Comfort Compression Sleeves (All Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in atrisk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism.
Reprocessed SCD™ Express Compression Sleeves (Small and Medium Sizes)
The Kendall SCD Compression System is designed to increase venous blood flow in atrisk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
6. Technological Characteristics:
The Reprocessed Compression Sleeves are identical to the predicate device in design, materials of construction, and intended use. There are no changes to the clinical applications, patient population, performance specifications, or method of operation.
7. Performance Data:
Representative samples of the Reprocessed Compression Sleeves were tested to demonstrate appropriate functional characteristics through bench top verification and cleaning validation. Testing included visual inspection, simulated use testing, leak testing and system compatibility verification. The manufacturing process includes visual and functional testing of all reprocessed products prior to release.
8. Conclusion:
Based on cleaning validation and functional testing, Covidien has demonstrated that the Reprocessed Compression Sleeves with one additional reprocessing cycle are substantially equivalent to the existing Reprocessed Compression Garment (K161105).
§ 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).