(13 days)
G060186, K992832
No
The device description focuses on the physical construction and materials of a vascular shunt, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are based on in vitro testing and comparisons to existing grafts, not on the performance of an AI/ML model.
Yes.
The device is intended to be used as a temporary bypass shunt in limb-threatening trauma cases where there has been damage to a major blood vessel, which is a therapeutic intervention.
No
The device is described as a "temporary bypass shunt" and a "vascular prosthesis" to facilitate the flow of blood. Its function is to replace or bypass a damaged blood vessel, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details a physical vascular prosthesis made of ePTFE and other materials, intended for surgical implantation. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to be used as a temporary bypass shunt in vivo (within the body) to repair damaged blood vessels.
- Device Description: The description details a physical vascular prosthesis designed for surgical implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples. This device is clearly designed for direct surgical intervention in vivo.
N/A
Intended Use / Indications for Use
"this device is intended to be used as a temporary bypass shunt in limb threatening trauma cases were there has been damage to a major blood vessel"
Product codes (comma separated list FDA assigned to the subject device)
DXC
Device Description
The Temporary Limb Salvage Shunt is a hybrid of two types of commercially available The Tomporary Limb Survage Sites Rapidax™ (G060186) and MAXIFLO™ (K992832). A summary of both grafts is detailed below.
The Vascutek Rapidax™ graft comprises an internal ePTFE vascular graft and an external eRTFE layer. These are identical to those used in the manufacture of the MAXIFLOTM Wrap grafts (Figure 1a). In the Rapidax™ graft these surfaces sandwich a self-sealing elastomer membrane has been subjected to in vitro and in vivo evaluation, both in animals and humans, which ensure its suitability for implant. A representative image of this triple layer effect is detailed in Figure 1b.
Vascutek Rapidax™ and MAXIFLO™ Wrap grafts are manufactured from virgin valouter · Raptad. " Rapidal above, this PTFE resin is identical to the porycollandoroun-florio (facture of Vascutek's other approved ePTFE vascular grafts. This material has an extensive history of use in cardiovascular and other medical applications material nas an offenererials have therefore been thoroughly tested and characterized with regard to biocompatibility, physical properties and suitability for the intended use.
The differences associated with the Temporary Limb Salvage Shunt are summarized as:
- The absence of the outer ePTFE layer
- The addition of a PTFE external support at both ends and middle of the TLSS
- The addition of measurement markings along the surface of the TLSS
The Temporary Limb Salvage Shunt is an ePTFE vascular prosthesis which has been modified to facilitate its use as a temporary limb salvage shunt. The device includes an modified to facilitate, external support and graduated markings to allow assessment of depth of insertion as shown in Figures 2 and 3. All these elements are included in the current approved range of Vascutek ePTFE vascular grafts.
The externally supported bevelled ends facilitate the placing of the device within the severed artery. The support in the centre of the device is required if a shorter length is needed to enable the trauma surgeon to cut the device to the required length. The selfsealing membrane permits drugs to be administered directly into the lumen without loss of ooaling mombrans pormatings assist the surgeon in placement of the correct length as illustrated in Figure 3. Specifications are detailed in Table 1.
The mechanical properties of the Vascutek Temporary Limb Salvage Shunt are rne moonahioan proper.commercial distribution. In vitro testing and other comparisons conducted on the Vascutek Temporary Limb Salvage Shunt show it to be equivalent to the current Vascutek ePTFE vascular grafts (K992832) and other devices used in the intended use application (K062474 : K052302 : K021213). Results from biocompatibility, animal and clinical studies, also demonstrate that the Vascutek Temporary Limb Salvage Shunt is biocompatible and non-toxic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
major blood vessel (in upper or lower limbs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Results from biocompatibility, animal and clinical studies, also demonstrate that the Vascutek Temporary Limb Salvage Shunt is biocompatible and non-toxic.
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.
G060186, K992832
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY
VASCUTEK TEMPORARY LIMB SALAVE SHUNT
Date prepared - 30 January 2007
FEB 1 5 2007
Page 1 of 3
| Common name of the Device: | Clamp, Vascular |
|---|---|
| Trade name or Proprietary Name: | Vascutek Temporary Limb Salvage Shunt |
| Classification Name: | Part 870 Cardiovascular Devices. Subpart E – Cardiovascular Surgical Devices. Vascular clamp (21 CFR 870.4450) |
| Applicant: | Karen Kelso |
| Regulatory Affairs Manager | |
| Vascutek Ltd. | |
| Newmains Avenue | |
| Inchinnan Industrial Estate | |
| Renfrewshire, Scotland | |
| PA4 9RR, United Kingdom | |
| Device Predicates: | McPherson Enterprises Inc. Smithwick Carotic Shunt (K062474) |
| Boston Scientific Corp. Hemashield Platinum Woven Double Velour TAAA Graft (K052302) | |
| Boston Scientific Corp. Hemashield Platinum Woven/Microvelour (K021213) | |
| Device Description: |
The Temporary Limb Salvage Shunt is a hybrid of two types of commercially available The Tomporary Limb Survage Sites Rapidax™ (G060186) and MAXIFLO™ (K992832). A summary of both grafts is detailed below.
The Vascutek Rapidax™ graft comprises an internal ePTFE vascular graft and an external eRTFE layer. These are identical to those used in the manufacture of the MAXIFLOTM Wrap grafts (Figure 1a). In the Rapidax™ graft these surfaces sandwich a
26
1
self-sealing elastomer membrane has been subjected to in vitro and in vivo evaluation, both in animals and humans, which ensure its suitability for implant. A representative image of this triple layer effect is detailed in Figure 1b.
Vascutek Rapidax™ and MAXIFLO™ Wrap grafts are manufactured from virgin valouter · Raptad. " Rapidal above, this PTFE resin is identical to the porycollandoroun-florio (facture of Vascutek's other approved ePTFE vascular grafts. This material has an extensive history of use in cardiovascular and other medical applications material nas an offenererials have therefore been thoroughly tested and characterized with regard to biocompatibility, physical properties and suitability for the intended use.
The differences associated with the Temporary Limb Salvage Shunt are summarized as:
- The absence of the outer ePTFE layer 1
- The addition of a PTFE external support at both ends and middle of the TLSS 2
- The addition of measurement markings along the surface of the TLSS 3
The Temporary Limb Salvage Shunt is an ePTFE vascular prosthesis which has been modified to facilitate its use as a temporary limb salvage shunt. The device includes an modified to facilitate, external support and graduated markings to allow assessment of depth of insertion as shown in Figures 2 and 3. All these elements are included in the current approved range of Vascutek ePTFE vascular grafts.
The externally supported bevelled ends facilitate the placing of the device within the severed artery. The support in the centre of the device is required if a shorter length is needed to enable the trauma surgeon to cut the device to the required length. The selfsealing membrane permits drugs to be administered directly into the lumen without loss of ooaling mombrans pormatings assist the surgeon in placement of the correct length as illustrated in Figure 3. Specifications are detailed in Table 1.
The mechanical properties of the Vascutek Temporary Limb Salvage Shunt are rne moonahioan proper.commercial distribution. In vitro testing and other comparisons conducted on the Vascutek Temporary Limb Salvage Shunt show it to be equivalent to the current Vascutek ePTFE vascular grafts (K992832) and other devices used in the intended use application (K062474 : K052302 : K021213). Results from biocompatibility, animal and clinical studies, also demonstrate that the Vascutek Temporary Limb Salvage Shunt is biocompatible and non-toxic.
Intended Use:
The intended use of the Temporary Limb Salvage Shunt is:
"this device is intended to be used as a temporary bypass shunt in limb threatening trauma cases were there has been damage to a major blood vessel"
Substantial Equivalence:
In conclusion, the Vascutek Temporary Limb Salvage Shunt is substantially equivalent to in ocholaston, the vacusation. All devices referenced under this current application are intended for use as arterial conduits.
2
11 summary, all testing and associated documentation demonstralies the Vascutek
t Vasculter of the finitial of the books to the tickly a guivelent to other devices in In summaly, and testing and association equivalent to other devices in provided in remporary Elmb Ourrago Onahi, voan, of this substantial equivalence is provided in Table 2 with comparison to the predicate devices.
Karen Kebo
........................................
Signature
....
.............................................................................................................................................................................. Date
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 5 2007
Vascutek Ltd. c/o Dr. Karen Kelso Newmains Ave. Inchinnan Industrial Estate Renfrewshire, Glasgow, Scotland, UK PA4 9RR
Re: K070323
Trade Name: Temporary Limb Salvage Shunt (TLSS) Regulation Number: 21 CFR 870.4450 Regulation Name: Clamp, Vascular Regulatory Class: Class II Product Code: DXC Dated: January 30, 2007 Received: February 2, 2007
Dear Dr. Kelso:
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. Iisting 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.
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
4
Page 2 - Dr. Kelso
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: VASCUTEK TEMPORARY LIMB SALVAGE SHUNT
Indications For Use: THIS DEVICE IS INTENDED TO BE USED AS A TEMPORARY BYPASS SHUNT IN LIMB THREATENING TRAUMA CASES WHERE THERE HAS BEEN DAMAGE TO A MAJOR BLOOD VESSEL
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number /K070523
Page 1 of 1
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