(13 days)
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
The Temporary Limb Salvage Shunt is a hybrid of two types of commercially available grafts, Rapidax™ (G060186) and MAXIFLO™ (K992832). 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. In the Rapidax™ graft these surfaces sandwich a self-sealing elastomer membrane. Vascutek Rapidax™ and MAXIFLO™ Wrap grafts are manufactured from virgin valouter. This PTFE resin is identical to the porycollandoroun-florio (facture of Vascutek's other approved ePTFE vascular grafts. 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. 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 self-sealing 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.
The provided text is a 510(k) summary for the Vascutek Temporary Limb Salvage Shunt (TLSS). It details the device's description, intended use, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or performance metrics in the format requested.
The 510(k) process for this type of medical device (a vascular clamp/shunt) primarily relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific performance criteria against a predefined set of metrics through a separate study with statistical endpoints.
Therefore, many of the requested fields cannot be filled based on the provided document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The acceptance criteria for 510(k) clearance are generally that the new device is "substantially equivalent" to predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
- Reported Device Performance: Not quantified in terms of specific performance metrics (e.g., success rates, complication rates, flow rates with statistical confidence intervals). The document states that the mechanical properties of the TLSS are "equivalent to other similar devices of this type already in commercial distribution" and that "in vitro testing and other comparisons" show it to be equivalent to current Vascutek ePTFE vascular grafts and other devices. It also mentions "Results from biocompatibility, animal and clinical studies, also demonstrate that the Vascutek Temporary Limb Salvage Shunt is biocompatible and non-toxic." However, no specific performance values or acceptance targets are provided.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "in vitro testing," "animal," and "clinical studies" but does not give sample sizes for any of these.
- Data Provenance: Not specified for the "clinical studies" mentioned. "In vitro" and "animal" studies are general categories.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is typically for diagnostic devices or AI algorithms that rely on expert interpretation of data. The TLSS is a surgical implant; its "ground truth" would be established through direct clinical outcomes or engineering performance.
4. Adjudication method for the test set:
- Not applicable/Not provided. This is relevant for studies involving human readers/interpreters.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No such study is mentioned or implied.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This relates to AI/diagnostic algorithms.
7. The type of ground truth used:
- Implicitly, engineering specifications, biocompatibility standards, and clinical outcomes data (from prior studies on similar devices). The document mentions "in vitro and in vivo evaluation," "biocompatibility, animal and clinical studies" that "ensure its suitability for implant." However, the specific ground truth used for each aspect is not detailed.
8. The sample size for the training set:
- Not applicable/Not provided. This relates to AI/machine learning models.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This relates to AI/machine learning models.
Summary based on available information:
| Criterion | Device Performance/Information from Document |
|---|---|
| Acceptance Criteria | Not explicitly defined as quantifiable metrics in this document. The overarching acceptance criterion for 510(k) clearance is "substantial equivalence" to predicate devices. This implicitly means the device must meet the safety and performance characteristics demonstrated by its predicates and not raise new questions of safety or effectiveness. |
| Reported Device Performance | "The mechanical properties of the Vascutek Temporary Limb Salvage Shunt are equivalent to other similar devices of this type already in 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." |
| Sample size (test set) | Not specified. |
| Data Provenance | Not specified beyond "in vitro," "animal," and "human" evaluation. |
| Number of experts for ground truth & qualifications | Not applicable (device is a surgical implant, not a diagnostic algorithm). |
| Adjudication method | Not applicable. |
| MRMC comparative effectiveness study? Effect size? | No. |
| Standalone (algorithm only) performance? | Not applicable. |
| Type of ground truth used | Implicit: Engineering specifications, biocompatibility standards, and existing clinical data from predicate devices. The document refers to "in vitro and in vivo evaluation," "biocompatibility, animal and clinical studies" to ensure suitability. |
| Sample size for training set | Not applicable (not an AI/ML device). |
| How ground truth for training set was established | Not applicable. |
Conclusion:
The provided 510(k) summary focuses on establishing substantial equivalence for the Vascutek Temporary Limb Salvage Shunt. It highlights that the device is a hybrid of existing, approved technologies and has undergone biocompatibility, in vitro, animal, and clinical evaluations to demonstrate its suitability and equivalence to predicate devices (McPherson Enterprises Inc. Smithwick Carotid Shunt K062474, Boston Scientific Corp. Hemashield Platinum Woven Double Velour TAAA Graft K052302, and Boston Scientific Corp. Hemashield Platinum Woven/Microvelour K021213). However, it does not specify quantitative acceptance criteria or detailed results from studies in the format typically used for performance claims of diagnostic or AI-driven medical devices. The clearance is based on the statutory requirement of substantial equivalence, meaning the device is as safe and effective as its predicates.
{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 KelsoRegulatory Affairs ManagerVascutek Ltd.Newmains AvenueInchinnan Industrial EstateRenfrewshire, ScotlandPA4 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
24
§ 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).