SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS

K101224 · Griffiths and Nielsen, Ltd. · DWL · Dec 3, 2010 · General Hospital

Device Facts

• Record ID: K101224
• Device Name: SAPHENAMEDICAL ANTI-EMBOLISM STOCKINGS
• Applicant: Griffiths and Nielsen, Ltd.
• Product Code: DWL · General Hospital
• Decision Date: Dec 3, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5780
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

SaphenaMEDICAL Anti-Embolism Stockings are ready-to-wear, graduated compression garments designed for post-operative, surgical, reclining, or bed-confined patients. Fabricated from nylon and lycra, the stockings apply controlled, uniform graduated compression to the legs to improve capillary and lymphatic drainage and reduce capillary leakage. Compression is highest at the ankle (approx. 18 mmHg), decreasing toward the mid-calf (14 mmHg) and upper thigh (8 mmHg). The device is used in clinical or home settings to manage edema, lymphedema, and prevent DVT by preventing blood pooling. It is non-sterile and latex-free. Healthcare providers or patients use the stockings to provide mechanical support, with sizing based on ankle, calf, and thigh circumferences.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing demonstrated that the device's safety and effectiveness are equivalent to the predicate devices in material content, function, and indication.

Technological Characteristics

Materials: Nylon and spandex (elastane/lycra). Construction: Circular knit. Compression: Graduated (10-20 mmHg range). Form factor: Knee-high and thigh-high styles. Energy source: Passive mechanical compression. Sterilization: Not stated.

Indications for Use

Indicated for post-operative, surgical, reclining, or bed-confined patients to prevent blood pooling, DVT, edema, and leg discomfort in individuals subjected to immobility.

Regulatory Classification

Identification

Medical support stocking to prevent the pooling of blood in the legs: 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. Medical support stocking for general medical purposes: 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.

Special Controls

*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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

Predicate Devices

• Anti-Embolism Stockings (K090921)
• Therafirm Anti-Embolism Stockings (K091141)
• Kendall T.ED. Anti-Embolism Stockings (K925417)
• CAP anti-embolism stockings (Grandfathered)

Submission Summary (Full Text)

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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

[phone] Telephone [phone] Fax

Establishment Registration Number:

Still to be obtained

Contact Person:

Edwin Lindsay

[phone] Telephone

Date Prepared:

8th November 2010

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For the SaphenaMEDICAL® Anti -Embolism Stocking 510(k) Summary

### Device Classification Information:

| Regulation<br>Number | Device Name | Device<br>Class | Product<br>Code | Classification<br>Panel |
|----------------------|-----------------------------------------------------------------------|-----------------|-----------------|-------------------------|
| 880.5780 | Stocking, Medical Support<br>(To Prevent Pooling of<br>Blood 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 of<br>Tyco Healthcare Group LP | Kendall T.ED. Anti-Embolism Stockings | K925417 |
| Carolon CO | CAP anti-embolism stockings | Approved Prior to 510k<br>Requirement –<br>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:<br>SaphenaMEDICAL<br>Anti-Embolism<br>Stockings | Anti-Embolism<br>Stockings | Therafirm Anti-<br>Embolism<br>Stockings | Kendall T.ED. Anti-<br>Embolism<br>Stockings | CAP anti-embolism<br>stockings |
|----------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Device<br>Manufacturer | Griffiths and Nielsen<br>Ltd | Beiersdorf INC. | Knit-Rite, INC. | KENDALL, a division<br>of Tyco Healthcare<br>Group LP | Carolon CO |
| Device Trade<br>/ Common<br>Name | SaphenaMEDICAL<br>Anti-Embolism<br>Stockings | Anti-Embolism<br>Stockings | Therafirm Anti-<br>Embolism Stockings | Kendall T.ED. Anti-<br>Embolism Stockings | CAP anti-embolism<br>stockings |
| 510(K)<br>Number | N/A | K090921 | K091141 | K925417 | Approved Prior to<br>510k Requirement -<br>Grandfathered |
| Device<br>Classification<br>name | Stocking, Medical<br>Support (To Prevent<br>Pooling of Blood In<br>Legs) | Stocking, Medical<br>Support (To Prevent<br>Pooling of Blood In<br>Legs) | Stocking, Medical<br>Support (To Prevent<br>Pooling of Blood In<br>Legs) | Stocking, Medical<br>Support (To Prevent<br>Pooling of Blood In<br>Legs) | Stocking, Medical<br>Support (To Prevent<br>Pooling of Blood In<br>Legs) |

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:<br>SaphenaMEDICAL<br>Anti-Embolism<br>Stockings | Anti-Embolism<br>Stockings | Therafirm Anti-<br>Embolism<br>Stockings | Kendall T.ED. Anti-<br>Embolism<br>Stockings | CAP anti-embolism<br>stockings |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification | Class II | Class II | Class II | Class II | Class II |
| Prescription<br>or Over the<br>Counter | Over the Counter | Over the Counter | Over the Counter | Over the Counter | Over the Counter |
| Materials | Nylon and spandex<br>(elastane /lycra) | Nylon and spandex<br>(elastane /lycra) | Nylon and spandex<br>(elastane /lycra) | Nylon and spandex<br>(elastane /lycra) | Nylon and spandex<br>(elastane /lycra) |
| Sizes | Small, Medium,<br>Large, Extra Large | Small, Medium,<br>Large, Extra Large,<br>Extra (x2) Large | Small, Medium,<br>Large, Extra Large,<br>Extra (x2) Large | Small, Medium,<br>Large, Extra Large | Small, Medium,<br>Large, Extra Large |
| Intended Use | Anti-Embolism<br>Stockings are to help<br>prevent edema, leg<br>discomfort, and deep<br>vein thrombosis or<br>individuals subjected<br>to immobility. | Anti-Embolism<br>Stockings are to help<br>prevent edema, leg<br>discomfort, and deep<br>vein thrombosis or<br>individuals subjected<br>to immobility. | Anti-Embolism<br>Stockings are to help<br>prevent edema, leg<br>discomfort, and deep<br>vein thrombosis or<br>individuals subjected<br>to immobility. | Anti-Embolism<br>Stockings are to help<br>prevent edema, leg<br>discomfort, and deep<br>vein thrombosis or<br>individuals subjected<br>to immobility. | Anti-Embolism<br>Stockings are to help<br>prevent edema, leg<br>discomfort, and deep<br>vein thrombosis or<br>individuals subjected<br>to immobility. |
| Intended<br>Location of<br>Use | Below the knee and<br>thigh-high stockings | Below the knee and<br>thigh-high stockings | Below the knee and<br>thigh-high stockings | Below the knee and<br>thigh-high stockings | Below the knee and<br>thigh-high stockings |
| Device<br>Description | The Anti-Embolism<br>Stockings are<br>designed for the<br>post-operative/<br>surgical , reclining or<br>bed-confined<br>patients | The Anti-Embolism<br>Stockings are<br>designed for the<br>post-operative/<br>surgical , reclining or<br>bed-confined<br>patients | The Anti-Embolism<br>Stockings are<br>designed for the<br>post-operative/<br>surgical , reclining or<br>bed-confined<br>patients | The Anti-Embolism<br>Stockings are<br>designed for the<br>post-operative/<br>surgical , reclining or<br>bed-confined.<br>patients | The Anti-Embolism<br>Stockings are<br>designed for the<br>post-operative/<br>surgical , reclining or<br>bed-confined<br>patients |
| Compression<br>Levels | 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 [phone] or [phone] 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: