(214 days)
Not Found
No
The device description and performance studies focus on mechanical compression and material properties, with no mention of AI or ML.
Yes.
The device is intended to prevent medical conditions like Deep Vein Thrombosis (DVT) and edema, which are therapeutic applications.
No
The device is intended to prevent medical conditions like DVT and edema, not to diagnose them.
No
The device description clearly states it is a physical product (stockings made of nylon and lycra) that provides compression, which is a hardware function. There is no mention of any software component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the SaphenaMEDICAL Anti-Embolism Stockings clearly state that they are physical garments applied to the legs to provide compression. They work externally on the body to prevent blood pooling and DVT.
- No Mention of Samples or Testing: There is no mention of the device interacting with biological samples or performing any kind of diagnostic test.
Therefore, the SaphenaMEDICAL Anti-Embolism Stockings are a physical medical device, not an In Vitro Diagnostic.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DWL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Legs, ankle, calf, thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
post-operative/ surgical, reclining or bed-confined patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5780 Medical support stocking.
(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.
0
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
1
For the SaphenaMEDICAL® Anti -Embolism Stocking 510(k) Summary
Device Classification Information:
| Regulation
Number | Device Name | Device
Class | Product
Code | Classification
Panel |
|----------------------|-----------------------------------------------------------------------|-----------------|-----------------|-------------------------|
| 880.5780 | Stocking, Medical Support
(To Prevent Pooling of
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 | ||
| Tyco Healthcare Group LP | Kendall T.ED. Anti-Embolism Stockings | K925417 |
| Carolon CO | CAP anti-embolism stockings | Approved Prior to 510k |
| Requirement – | ||
| 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.
2
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:
SaphenaMEDICAL
Anti-Embolism
Stockings | Anti-Embolism
Stockings | Therafirm Anti-
Embolism
Stockings | Kendall T.ED. Anti-
Embolism
Stockings | CAP anti-embolism
stockings |
|----------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Device
Manufacturer | Griffiths and Nielsen
Ltd | Beiersdorf INC. | Knit-Rite, INC. | KENDALL, a division
of Tyco Healthcare
Group LP | Carolon CO |
| Device Trade
/ Common
Name | SaphenaMEDICAL
Anti-Embolism
Stockings | Anti-Embolism
Stockings | Therafirm Anti-
Embolism Stockings | Kendall T.ED. Anti-
Embolism Stockings | CAP anti-embolism
stockings |
| 510(K)
Number | N/A | K090921 | K091141 | K925417 | Approved Prior to
510k Requirement -
Grandfathered |
| Device
Classification
name | Stocking, Medical
Support (To Prevent
Pooling of Blood In
Legs) | Stocking, Medical
Support (To Prevent
Pooling of Blood In
Legs) | Stocking, Medical
Support (To Prevent
Pooling of Blood In
Legs) | Stocking, Medical
Support (To Prevent
Pooling of Blood In
Legs) | Stocking, Medical
Support (To Prevent
Pooling of Blood In
Legs) |
A comparison is presented in the table below:
3
K101 224
For the SaphenaMEDICAL® Anti -Embolism Stocking ------------------------------------------------------------------------------------------------------------------------------510(k) Summary
| Property | New Device:
SaphenaMEDICAL
Anti-Embolism
Stockings | Anti-Embolism
Stockings | Therafirm Anti-
Embolism
Stockings | Kendall T.ED. Anti-
Embolism
Stockings | CAP anti-embolism
stockings |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification | Class II | Class II | Class II | Class II | Class II |
| Prescription
or Over the
Counter | 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-Embolism
Stockings are to help
prevent edema, leg
discomfort, and deep
vein thrombosis or
individuals subjected
to immobility. | Anti-Embolism
Stockings are to help
prevent edema, leg
discomfort, and deep
vein thrombosis or
individuals subjected
to immobility. | Anti-Embolism
Stockings are to help
prevent edema, leg
discomfort, and deep
vein thrombosis or
individuals subjected
to immobility. | Anti-Embolism
Stockings are to help
prevent edema, leg
discomfort, and deep
vein thrombosis or
individuals subjected
to immobility. | Anti-Embolism
Stockings are to help
prevent edema, leg
discomfort, and deep
vein thrombosis or
individuals subjected
to immobility. |
| Intended
Location of
Use | Below the knee and
thigh-high stockings | Below the knee and
thigh-high stockings | Below the knee and
thigh-high stockings | Below the knee and
thigh-high stockings | Below the knee and
thigh-high stockings |
| Device
Description | The Anti-Embolism
Stockings are
designed for the
post-operative/
surgical , reclining or
bed-confined
patients | The Anti-Embolism
Stockings are
designed for the
post-operative/
surgical , reclining or
bed-confined
patients | The Anti-Embolism
Stockings are
designed for the
post-operative/
surgical , reclining or
bed-confined
patients | The Anti-Embolism
Stockings are
designed for the
post-operative/
surgical , reclining or
bed-confined.
patients | The Anti-Embolism
Stockings are
designed for the
post-operative/
surgical , reclining or
bed-confined
patients |
| Compression
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.
4
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.
5
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.
6
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
7
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: