(214 days)
SaphenaMEDICAL Anti-Embolism Stockings are intended to:
- Help to prevent the pooling of blood in the legs by applying controlled pressure to the legs.
- Help to prevent Deep Vein Thrombosis (DVT) and, edema and leg discomfort in . individuals subjected to immobility.
SaphenaMEDICAL Anti-Embolism Stockings are ready-to-wear for post-operative/ surgical, reclining or bed-confined patients, to help prevent pooling of blood and fluid in the extremities by applying controlled graduated pressure. The fabric used is comprised of nylon and lycra which is used in the predicate devices.
The SaphenaMEDICAL Anti-Embolism Stockings provide controlled, uniform graduated conpression, as is provided in all of these substantially equivalent products, starting with more compression circumferentially at the ankle at approximately 18 mmHg (based on average ankle size) then gradually decreases up to the proximal end. (14mmHg at the mid-calf and 8mmHg at the upper thigh)
Compression for the SaphenaMEDICAL Anti-Embolism Stockings, as well as all the predicate devices, is provided by lycra that acts circumferentially on the extremity. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic drainage and/or absorption. Consequently, they can be used to manage the same indications, i.e. edema and lymphedema.
The Anti-Embolism Stockings are not made with natural rubber latex.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the SaphenaMEDICAL® Anti-Embolism Stocking as substantially equivalent to existing predicate devices. Since this is a substantial equivalence submission, the acceptance criteria are implicitly aligned with the performance characteristics of the predicate devices. The reported device performance is presented as being equivalent to these predicates.
| Property/Acceptance Criteria | Reported Device Performance (SaphenaMEDICAL® Anti-Embolism Stocking) |
|---|---|
| Intended Use | Help to prevent the pooling of blood in the legs by applying controlled pressure to the legs. Help to prevent Deep Vein Thrombosis (DVT) and, edema and leg discomfort in individuals subjected to immobility. |
| Device Classification | Class II |
| Prescription or Over the Counter | Over the Counter |
| Materials | Nylon and spandex (elastane / lycra) |
| Sizes Available | Small, Medium, Large, Extra Large |
| Intended Location of Use | Below the knee and thigh-high stockings |
| Device Description (Target Population) | Designed for post-operative/surgical, reclining or bed-confined patients. |
| Compression Levels (Graduated) | 10-20 mmHg (specifically: approximately 18 mmHg at ankle, 14 mmHg at mid-calf, 8 mmHg at upper thigh) |
| Material Content | Equivalent to predicate products |
| Function | Equivalent to predicate products |
| Indication Bench Testing | Demonstrated safety and effectiveness equivalent to predicate devices. |
| Overall Safety and Effectiveness | Safe, effective, and performs as intended, substantially equivalent to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "Performance Data: The Anti-Embolism products being submitted are substantially equivalent to the predicate product in material content, function and indication bench testing demonstrated that the safety and effectiveness of the SaphenaMEDICAL Anti-Embolism Stockings is equivalent to the predicate devices."
This indicates that the evaluation of the SaphenaMEDICAL® Anti-Embolism Stocking was primarily based on bench testing and comparison to predicate devices, not a clinical study involving human subjects or a test set of data in the way one might evaluate an AI algorithm. Therefore, there is no explicit sample size mentioned for a "test set" in the context of patient data.
The "data provenance" is derived from the established performance and characteristics of the predicate devices, which are already legally marketed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Given that this is a 510(k) submission for substantial equivalence based on bench testing and comparison to predicate devices, there is no mention of experts establishing a ground truth for a test set in the context of clinical data or image interpretation. The "ground truth" here is the established performance and safety of the predicate devices, as recognized by regulatory bodies.
4. Adjudication Method for the Test Set:
Not applicable, as there was no clinical test set requiring adjudication in the way an AI algorithm's performance might be evaluated. The evaluation focused on bench testing and comparison to predicate specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs without AI assistance:
Not applicable. This submission is for a physical medical device (anti-embolism stockings), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is not an algorithm, so standalone performance is not relevant in this context.
7. The Type of Ground Truth Used:
The ground truth used for this submission is implicitly the established performance and safety profiles of the legally marketed predicate devices. The SaphenaMEDICAL® Anti-Embolism Stocking demonstrates substantial equivalence through its material content, function, indications for use, and bench testing results aligning with these predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" of data.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of medical device.
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K10124
For the SaphenaMEDICAL® Anti -Embolism Stocking 510(k) Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.
Submitter's Name:
:j.j.
Griffiths and Nielsen Ltd
Submitter's Address:
DEC 3 2010
Griffiths and Nielsen Ltd Stane Street, Slinfold, Horsham, West Sussex, United Kingdom RH13 OTW
+44 (0) 0845 263 8908 Telephone +44 (0) 0845 263 8907 Fax
Establishment Registration Number:
Still to be obtained
Contact Person:
Edwin Lindsay
+44 (0) 7917134922 Telephone
Date Prepared:
8th November 2010
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For the SaphenaMEDICAL® Anti -Embolism Stocking 510(k) Summary
Device Classification Information:
| RegulationNumber | Device Name | DeviceClass | ProductCode | ClassificationPanel |
|---|---|---|---|---|
| 880.5780 | Stocking, Medical Support(To Prevent Pooling ofBlood In Legs) | Class 2 | DWL | General Hospital |
Device Trade Name:
Anti-Embolism Stockings
Device Common Name:
SaphenaMEDICAL Anti-Embolism Stockings
Intended Use/Indications for Use:
SaphenaMEDICAL Anti-Embolism Stockings are intended to:
- Help to prevent the pooling of blood in the legs by applying controlled pressure to the legs.
- Help to prevent Deep Vein Thrombosis (DVT) and, edema and leg discomfort in . individuals subjected to immobility.
Summary of Substantial Equivalence:
The SaphenaMEDICAL Anti-Embolism Stockings are substantially equivalent to the following predicate devices with respect to the intended use/indications for use, and the technological characteristics:
| Company Name | Product Details | 510(k) Number |
|---|---|---|
| Beiersdorf INC. | Anti-Embolism Stockings | K090921 |
| Knit-Rite, INC. | Therafirm Anti-Embolism Stockings | K091141 |
| KENDALL, a division ofTyco Healthcare Group LP | Kendall T.ED. Anti-Embolism Stockings | K925417 |
| Carolon CO | CAP anti-embolism stockings | Approved Prior to 510kRequirement –Grandfathered |
The SaphenaMEDICAL Anti-Embolism Stockings and their substantial equivalents, mentioned above, are knit on circular knit machines with nylon and spandex. They all include knee-high and thigh-high styles. The knee-high is sized based on ankle and calf circumferences, while the thigh high is sized based on ankle, calf, and thigh circumference fit.
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For the SaphenaMEDICAL® Anti -Embolism Stocking 510(k) Summary
Device Description:
SaphenaMEDICAL Anti-Embolism Stockings are ready-to-wear for post-operative/ surgical, reclining or bed-confined patients, to help prevent pooling of blood and fluid in the extremities by applying controlled graduated pressure. The fabric used is comprised of nylon and lycra which is used in the predicate devices.
The SaphenaMEDICAL Anti-Embolism Stockings provide controlled, uniform graduated conpression, as is provided in all of these substantially equivalent products, starting with more compression circumferentially at the ankle at approximately 18 mmHg (based on average ankle size) then gradually decreases up to the proximal end. (14mmHg at the mid-calf and 8mmHg at the upper thigh)
Compression for the SaphenaMEDICAL Anti-Embolism Stockings, as well as all the predicate devices, is provided by lycra that acts circumferentially on the extremity. The gradient compression present in these products helps reduce capillary leakage and improve capillary and lymphatic drainage and/or absorption. Consequently, they can be used to manage the same indications, i.e. edema and lymphedema.
The Anti-Embolism Stockings are not made with natural rubber latex.
Technological Characteristics:
A comparative review of the SaphenaMEDICAL Anti-Embolism Stockings with the predicate A comparative reviour of the objical characteristics, performance and principle of operation were substantially equivalent.
| Property | New Device:SaphenaMEDICALAnti-EmbolismStockings | Anti-EmbolismStockings | Therafirm Anti-EmbolismStockings | Kendall T.ED. Anti-EmbolismStockings | CAP anti-embolismstockings |
|---|---|---|---|---|---|
| DeviceManufacturer | Griffiths and NielsenLtd | Beiersdorf INC. | Knit-Rite, INC. | KENDALL, a divisionof Tyco HealthcareGroup LP | Carolon CO |
| Device Trade/ CommonName | SaphenaMEDICALAnti-EmbolismStockings | Anti-EmbolismStockings | Therafirm Anti-Embolism Stockings | Kendall T.ED. Anti-Embolism Stockings | CAP anti-embolismstockings |
| 510(K)Number | N/A | K090921 | K091141 | K925417 | Approved Prior to510k Requirement -Grandfathered |
| DeviceClassificationname | Stocking, MedicalSupport (To PreventPooling of Blood InLegs) | Stocking, MedicalSupport (To PreventPooling of Blood InLegs) | Stocking, MedicalSupport (To PreventPooling of Blood InLegs) | Stocking, MedicalSupport (To PreventPooling of Blood InLegs) | Stocking, MedicalSupport (To PreventPooling of Blood InLegs) |
A comparison is presented in the table below:
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K101 224
For the SaphenaMEDICAL® Anti -Embolism Stocking ------------------------------------------------------------------------------------------------------------------------------510(k) Summary
| Property | New Device:SaphenaMEDICALAnti-EmbolismStockings | Anti-EmbolismStockings | Therafirm Anti-EmbolismStockings | Kendall T.ED. Anti-EmbolismStockings | CAP anti-embolismstockings |
|---|---|---|---|---|---|
| DeviceClassification | Class II | Class II | Class II | Class II | Class II |
| Prescriptionor Over theCounter | Over the Counter | Over the Counter | Over the Counter | Over the Counter | Over the Counter |
| Materials | Nylon and spandex(elastane /lycra) | Nylon and spandex(elastane /lycra) | Nylon and spandex(elastane /lycra) | Nylon and spandex(elastane /lycra) | Nylon and spandex(elastane /lycra) |
| Sizes | Small, Medium,Large, Extra Large | Small, Medium,Large, Extra Large,Extra (x2) Large | Small, Medium,Large, Extra Large,Extra (x2) Large | Small, Medium,Large, Extra Large | Small, Medium,Large, Extra Large |
| Intended Use | Anti-EmbolismStockings are to helpprevent edema, legdiscomfort, and deepvein thrombosis orindividuals subjectedto immobility. | Anti-EmbolismStockings are to helpprevent edema, legdiscomfort, and deepvein thrombosis orindividuals subjectedto immobility. | Anti-EmbolismStockings are to helpprevent edema, legdiscomfort, and deepvein thrombosis orindividuals subjectedto immobility. | Anti-EmbolismStockings are to helpprevent edema, legdiscomfort, and deepvein thrombosis orindividuals subjectedto immobility. | Anti-EmbolismStockings are to helpprevent edema, legdiscomfort, and deepvein thrombosis orindividuals subjectedto immobility. |
| IntendedLocation ofUse | Below the knee andthigh-high stockings | Below the knee andthigh-high stockings | Below the knee andthigh-high stockings | Below the knee andthigh-high stockings | Below the knee andthigh-high stockings |
| DeviceDescription | The Anti-EmbolismStockings aredesigned for thepost-operative/surgical , reclining orbed-confinedpatients | The Anti-EmbolismStockings aredesigned for thepost-operative/surgical , reclining orbed-confinedpatients | The Anti-EmbolismStockings aredesigned for thepost-operative/surgical , reclining orbed-confinedpatients | The Anti-EmbolismStockings aredesigned for thepost-operative/surgical , reclining orbed-confined.patients | The Anti-EmbolismStockings aredesigned for thepost-operative/surgical , reclining orbed-confinedpatients |
| CompressionLevels | 10-20 mmHg | 10-20 mmHg | 10-20 mmHg | 10-20 mmHg | 10-20 mmHg |
Performance Data:
The Anti-Embolism products being submitted are substantially equivalent to the predicate product in material content, function and indication bench testing demonstrated that the safety and effectiveness of the SaphenaMEDICAL Anti-Embolism Stockings is equivalent to the predicate devices.
This statement is to assure that SaphenaMEDICAL Anti-Embolism Stockings are safe and rfils Statement is to about that bephen see and fit properly according to the guidelines.
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For the SaphenaMEDICAL® Anti -Embolism Stocking 510(k) Summary
See Section 18 on Performance Testing - Bench for nonclinical testing that demonstrates that See Section To on I enomiano Tooting - Decomparison to predicate devices.
Safety and Effectiveness:
The SaphenaMEDICAL Anti-Embolism Stockings utilises similar technology currently found in The SaphenaMEDICAL Anti-Enbolish Dased on testing and comparison with the predicate legally marketed predicate uevices. Dased on Stocking and colorse indications of devices, the SaphenaMEDICAL Anti-Enbollsin Cooking are safe, and Stockings are safe,
results. It is our determination that the SaphenaMEDICAL anti-Shockings are safe, results. It is our delemination that the Gapnerialians and is substantially equivalent to the predicate device.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract, wave-like shapes stacked vertically.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Edwin Lindsay Quality and Regulatory Specialist Griffiths and Nielsen Limited Stane Street, Slinfold Horsham, West Sussex United Kingdom RH13 0TW
DEC - 3 2010
Re: K101224
Trade/Device Name: SaphenaMEDICAL® Anti-Embolism Stocking Regulation Number: 21 CFR 880.5780 Regulation Name: Medical Support Stocking Regulatory Class: II Product Code: DWL Dated: November 8, 2010 Received: November 15, 2010
Dear Mr. Lindsay:
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.
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Page 2- Mr. Lindsay
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-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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, . please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and dental Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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For the SaphenaMEDICAL® Anti -Embolism Stocking
Indications for Use
510(k) Number (if known):K | ○ | ブスイ
Device Name: SaphenaMEDICAL® Anti -Embolism Stocking
Indications for Use:
SaphenaMEDICAL Anti-Embolism Stockings are intended to:
- Help to prevent the pooling of blood in the legs by applying controlled pressure to
- Help to prevent Deep Vein Thrombosis (DVT) and also edema and leg discomfort, and leg discomfort, and in idividuals subjected to immobility.
Prescription Use Part 21 CFR 801 Subpart D)
ge 1 of 1
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
:oncurrence of CDRH, Office of Device Evaluation (ODE)
Richard C. Chen
DEC - 3 2010
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devises Division of Antrol, Dental Devices
510(k) Number:
§ 880.5780 Medical support stocking.
Link to an amendment published at 90 FR 55987, Dec. 4, 2025. (a)
Medical support stocking to prevent the pooling of blood in the legs —(1)Identification. A medical support stocking to prevent the pooling of blood in the legs is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for use in the prevention of pooling of blood in the leg.(2)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.(b)
Medical support stocking for general medical purposes —(1)Identification. A medical support stocking for general medical purposes is a device that is constructed of elastic material and designed to apply controlled pressure to the leg and that is intended for medical purposes other than the prevention of pooling of blood in the leg.(2)
Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.