(109 days)
Not Found
No
The summary describes a physical medical device (a catheter) with a heparin coating and provides performance data based on in-vitro and animal studies. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a chronic hemodialysis catheter, which is used for a medical treatment (hemodialysis) to remove waste products from the blood of patients with kidney failure, thus performing a therapeutic function. The heparin coating also contributes to its therapeutic effectiveness by reducing clotting.
No
The device is a chronic hemodialysis catheter, used for treatment (hemodialysis and apheresis), not for diagnosing a condition. Its function is to facilitate blood flow for these procedures, and its coating is designed to reduce thrombus formation, which is a therapeutic rather than a diagnostic function.
No
The device is a physical catheter with a coating, not a software program. The description details the material, dimensions, and coating technology of a tangible medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter is a medical device designed for direct insertion into the body (specifically, the femoral vein) for the purpose of chronic hemodialysis and apheresis. It is a therapeutic device used to facilitate a medical procedure, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly states "chronic Hemodialysis and apheresis," which are medical treatments, not diagnostic procedures.
- Performance Studies: The performance studies described focus on the device's ability to reduce thrombus formation in vivo (in animals) and in vitro (using blood circulation through the catheter), which relates to the device's function within the body or simulating its function, not a diagnostic test on a patient sample.
While the device utilizes in vitro testing to support its claims about the coating's effectiveness, the device itself is not an IVD. The in vitro testing is a method used to evaluate the performance of the device, not the device's primary function as a diagnostic tool.
N/A
Intended Use / Indications for Use
Spire Biomedical Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown.
The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing.
The catheters are offered in 24cm, 28cm, 32cm, 36cm, 40cm and 55cm lengths.
Catheters longer than 40cm are intended for femoral vein insertion.
Product codes
MSD
Device Description
Spire Biomedical, Inc.'s 15.5Fr Decathlon Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Coated catheters are fully coated with CBAS® on the internal surface and on external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated).
The coating is essentially non-leaching. Additionally, maximum amount of heparin on the surface is only 1mg. Therefore, even the effect on a patient's coagulation status would be totally insignificant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral vein
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)
Product Claims / In-vitro Studies:
Two in-vitro studies demonstrated that the proprietary End-Point Bonded Heparin Coating attachment mechanism anchors heparin molecules to both internal and external surfaces of the catheter while maintaining heparin's bioactive properties for a minimum of 90 days.
Coating bioactivity was assessed in 90-day durability tests performed on coated catheters in saline. Surface-bound heparin bioactivity (in pmol/cm2) was assessed at each of 7 regular intervals. Heparin bioactivity remained essentially constant throughout the test period, demonstrating that the coating's bioactive properties were maintained.
Animal and in-vitro studies have demonstrated that the coating reduces total thrombus accumulation by 94% and 96%%, respectively, compared to uncoated catheters. The coating was effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft).
The two-hour in-vitro thromboresistance study involved circulation of bovine blood through an outer loop, in which a coated or uncoated catheter was placed. Simultaneously, blood is circulated through the catheter at a constant flow rate. Three criteria are used to determine the effects of the coating in reducing thrombus formation: Pressure increase in the arterial lumen; visual evaluation of the catheters; and end point thrombus accumulation. Results show improved thromboresistance using each of these criteria for Decathlon Coated catheters vs. uncoated catheters. End-point thrombus radiolabeled measurements showed an average of 96% reduction in thrombus accumulation for two hours for coated catheters.
Animal Studies:
One coated and one uncoated catheter was evaluated in each of three animals (ovine). In each, mock dialysis sessions were performed once a week for 1 hour. The catheters were then examined at sacrifice (26-30 days, mean 29 days) using optical and scanning electron microscopy. In each case, the results showed a difference in thrombus accumulation between coated and uncoated Decathlon catheters. Thrombus weight measurements were also performed on two of the animals and showed that the coated Decathlon catheter reduced total thrombus accumulation by 94% when compared with the uncoated Decathlon catheter in the ovine model.
Performance Data / Additional Tests Conducted:
- Durability testing (bioactivity) for 90 days
- Durability testing (accelerated aging for up to 1 year)
- In-vitro blood loop testing 2-hour UAH study
- Animal (ovine) studies (mean duration 29 days)
- Catheter flows (bench testing)
- Mechanical properties (tensile strength)
- Biocompatibility testing was conducted on the 15.5Fr Decathion coated catheter to demonstrate that this device meets the requirements for a permanent contact device per ISO 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Reduces total thrombus accumulation by 94% and 96% (compared to uncoated catheters)
- 96% reduction in thrombus accumulation for two hours for coated catheters (in-vitro radiolabeled measurements)
- 94% reduction in total thrombus accumulation in ovine model for coated Decathlon catheter
Predicate Device(s)
K925626, K933586, K970906, P900043/S024
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5540 Blood access device and accessories.
(a)
Identification. A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.(1) The implanted blood access device is a prescription device and consists of various flexible or rigid tubes, such as catheters, or cannulae, which are surgically implanted in appropriate blood vessels, may come through the skin, and are intended to remain in the body for 30 days or more. This generic type of device includes various catheters, shunts, and connectors specifically designed to provide access to blood. Examples include single and double lumen catheters with cuff(s), fully subcutaneous port-catheter systems, and A-V shunt cannulae (with vessel tips). The implanted blood access device may also contain coatings or additives which may provide additional functionality to the device.
(2) The nonimplanted blood access device consists of various flexible or rigid tubes, such as catheters, cannulae or hollow needles, which are inserted into appropriate blood vessels or a vascular graft prosthesis (§§ 870.3450 and 870.3460), and are intended to remain in the body for less than 30 days. This generic type of device includes fistula needles, the single needle dialysis set (coaxial flow needle), and the single needle dialysis set (alternating flow needle).
(3) Accessories common to either type include the shunt adaptor, cannula clamp, shunt connector, shunt stabilizer, vessel dilator, disconnect forceps, shunt guard, crimp plier, tube plier, crimp ring, joint ring, fistula adaptor, and declotting tray (including contents).
(b)
Classification. (1) Class II (special controls) for the implanted blood access device. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible. Material names and specific designation numbers must be provided.
(ii) Performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(A) Pressure versus flow rates for both arterial and venous lumens, from the minimum flow rate to the maximum flow rate in 100 milliliter per minute increments, must be established. The fluid and its viscosity used during testing must be stated.
(B) Recirculation rates for both forward and reverse flow configurations must be established, along with the protocol used to perform the assay, which must be provided.
(C) Priming volumes must be established.
(D) Tensile testing of joints and materials must be conducted. The minimum acceptance criteria must be adequate for its intended use.
(E) Air leakage testing and liquid leakage testing must be conducted.
(F) Testing of the repeated clamping of the extensions of the catheter that simulates use over the life of the device must be conducted, and retested for leakage.
(G) Mechanical hemolysis testing must be conducted for new or altered device designs that affect the blood flow pattern.
(H) Chemical tolerance of the device to repeated exposure to commonly used disinfection agents must be established.
(iii) Performance data must demonstrate the sterility of the device.
(iv) Performance data must support the shelf life of the device for continued sterility, package integrity, and functionality over the requested shelf life that must include tensile, repeated clamping, and leakage testing.
(v) Labeling of implanted blood access devices for hemodialysis must include the following:
(A) Labeling must provide arterial and venous pressure versus flow rates, either in tabular or graphical format. The fluid and its viscosity used during testing must be stated.
(B) Labeling must specify the forward and reverse recirculation rates.
(C) Labeling must provide the arterial and venous priming volumes.
(D) Labeling must specify an expiration date.
(E) Labeling must identify any disinfecting agents that cannot be used to clean any components of the device.
(F) Any contraindicated disinfecting agents due to material incompatibility must be identified by printing a warning on the catheter. Alternatively, contraindicated disinfecting agents must be identified by a label affixed to the patient's medical record and with written instructions provided directly to the patient.
(G) Labeling must include a patient implant card.
(H) The labeling must contain comprehensive instructions for the following:
(
1 ) Preparation and insertion of the device, including recommended site of insertion, method of insertion, and a reference on the proper location for tip placement;(
2 ) Proper care and maintenance of the device and device exit site;(
3 ) Removal of the device;(
4 ) Anticoagulation;(
5 ) Management of obstruction and thrombus formation; and(
6 ) Qualifications for clinical providers performing the insertion, maintenance, and removal of the devices.(vi) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices that include subcutaneous ports must include the following:
(A) Labeling must include the recommended type of needle for access as well as detailed instructions for care and maintenance of the port, subcutaneous pocket, and skin overlying the port.
(B) Performance testing must include results on repeated use of the ports that simulates use over the intended life of the device.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(vii) In addition to Special Controls in paragraphs (b)(1)(i) through (v) of this section, implanted blood access devices with coatings or additives must include the following:
(A) A description and material characterization of the coating or additive material, the purpose of the coating or additive, duration of effectiveness, and how and where the coating is applied.
(B) An identification in the labeling of any coatings or additives and a summary of the results of performance testing for any coating or material with special characteristics, such as decreased thrombus formation or antimicrobial properties.
(C) A Warning Statement in the labeling for potential allergic reactions including anaphylaxis if the coating or additive contains known allergens.
(D) Performance data must demonstrate efficacy of the coating or additive and the duration of effectiveness.
(viii) The following must be included for A-V shunt cannulae (with vessel tips):
(A) The device must comply with Special Controls in paragraphs (b)(1)(i) through (v) of this section with the exception of paragraphs (b)(1)(ii)(B), (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), which do not apply.
(B) Labeling must include Warning Statements to address the potential for vascular access steal syndrome, arterial stenosis, arterial thrombosis, and hemorrhage including exsanguination given that the device accesses the arterial circulation.
(C) Clinical performance testing must demonstrate safe and effective use and capture any adverse events observed during clinical use.
(2) Class II (performance standards) for the nonimplanted blood access device.
(3) Class II (performance standards) for accessories for both the implanted and the nonimplanted blood access devices not listed in paragraph (b)(4) of this section.
(4) Class I for the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device. The devices subject to this paragraph (b)(4) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
K060155 Azg21 of.
Image /page/0/Picture/1 description: The image shows the logo for Spire Biomedical. The logo consists of the word "spire" in a bold, sans-serif font, with the word "Biomedical" in a smaller, italicized font underneath. Above the word "spire" is a circular symbol that resembles a sun or a stylized flower.
Spire Biomedical, Inc., . One Patriots Park . Bedford, MA 01730-2396 TEL (781) 275-6000 •FAX 781 275 6010
SECTION 5 - 510(k) SUMMARY
MAY - 9 205
15.5Fr Decathlon Coated Catheters
Date: January 18, 2006
- Submitter: Spire Biomedical, Inc. One Patriots Park Bedford, MA 01730-2396 Phone: (781) 275-6000 Fax: (781) 275-7470
- Contact Person: Donald Fickett Director of RA/QA Spire Biomedical, Inc. Phone: (781) 275-6001 x221 Fax: (781) 275-6010 email: dfickett@spirecorp.com
Device Names:
| Trade Name: | 15.5Fr Decathlon Coated Catheters |
|---|---|
| Common Name: | Catheter, Intravascular, Long-Term |
| Classification Name: | Catheter, Hemodialysis, Implant (Long-Term) |
| Classification: | Class III |
| Device Code: | 78 MSD |
Device Description:
Spire Biomedical, Inc.'s 15.5Fr Decathlon Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the device. The coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Coated catheters are fully coated with CBAS® on the internal surface and on external surface of the catheter body (from 2cm distal to the cuff to the ends of the distal tips; the cuff is not coated).
The coating is essentially non-leaching. Additionally, maximum amount of heparin on the surface is only 1mg. Therefore, even the effect on a patient's coagulation status would be totally insignificant.
the contraction
1
Page 2 of 3
Image /page/1/Picture/2 description: The image shows the logo for Spire Biomedical. The logo consists of the word "spire" in bold, sans-serif font, with the word "Biomedical" in a smaller, cursive font underneath. Above the word "spire" is a circular symbol with radiating lines, resembling a sun or a stylized flower.
Spire Biomedical, Inc., · One Patriots Park · Bedford, MA 01730-2396 TEL (781) 275-6000 ●FAX 781 275 6010
SECTION 5 - 510(k) SUMMARY (Continued)
PRODUCT CLAIMS:
As demonstrated in two in-vitro studies, the proprietary End-Point Bonded Heparin Coating attachment mechanism anchors heparin molecules to both internal and external surfaces of the catheter while maintaining heparin's bioactive properties for a minimum of 90 days.1
Coating bioactivity was assessed in 90-day durability tests performed on coated catheters in saline. Surface-bound heparin bioactivity (in pmol/cm2) was assessed at each of 7 regular intervals. Heparin bioactivity remained essentially constant throughout the test period, demonstrating that the coating's bioactive properties were maintained.
Animal and in-vitro studies have demonstrated that the coating reduces total thrombus accumulation by 94% and 96%%, respectively, compared to uncoated catheters. The coating was effective in mitigating both disturbed flow-mediated thrombosis (at the catheter tip) and fibrin sheath propagation (on the catheter shaft).1
The two-hour in-vitro thromboresistance study involved circulation of bovine blood through an outer toop, in which a coated or uncoated catheter was placed. Simultaneously, blood is circulated through the catheter at a constant flow rate. Three criteria are used to determine the effects of the coating in reducing thrombus formation: Pressure increase in the arterial lumen; visual evaluation of the catheters; and end point thrombus accumulation. Results show improved thromboresistance using each of these criteria for Decathlon Coated catheters vs. uncoated catheters. End-point thrombus radiolabeled measurements showed an average of 96% reduction in thrombus accumulation for two hours for coated catheters.
One coated and one uncoated catheter was evaluated in each of three animals (ovine). In each, mock dialysis sessions were performed once a week for 1 hour. The catheters were then examined at sacrifice (26-30 days, mean 29 days) using optical and scanning electron microscopy. In each case, the results showed a difference in thrombus accumulation between coated and uncoated Decathlon catheters. Thrombus weight measurements were also performed on two of the animals and showed that the coated Decathlon catheter reduced total thrombus accumulation by 94% when compared with the uncoated Decathlon catheter in the ovine model.
1 Data on file
2
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Spire Biomedical, Inc., · One Patriots Park · Bedford, MA 01730-2396 TEL (781) 275-6000 ·FAX 781 275 6010
SECTION 5 - 510(k) SUMMARY (Continued)
Technological Characteristics Comparison to Predicate Devices:
The 15.5Fr Decathlon coated catheter is identical to the non-coated Decathlon catheter in physical characteristics.
Carmeda® BioActive Surface (CBAS®) coating has been approved for the following legally marketed devices to which substantial equivalence is claimed:
-
- Diametrics Paratrend intravascular blood gas sensor catheter (K970906)
-
- Cordis Bx Velocity coronary stent (P900043/S024)
Performance Data:
A series of physical tests were conducted to demonstrate substantial equivalence to our nontreated "Decathion" catheters including catheter to hub, extension to hub, luer adapter to extensions, cuff to catheter and catheter extrusion.
The following additional tests were conducted on the coated Decathlon catheters to demonstrate coating stability and performance claims:
- Durability testing (bioactivity) for 90 days .
- Durability testing (accelerated aging for up to 1 year) �
- In-vitro blood loop testing 2-hour UAH study .
- . (3) Animal (ovine) studies (mean duration 29 days)
- Catheter flows (bench testing) ●
- Mechanical properties (tensile strength) ◆
Biocompatibility testing was conducted on the 15.5Fr Decathion coated catheter to demonstrate that this device meets the requirements for a permanent contact device per ISO 10993.
3
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Donald D. Fickett, C.Q.E. Director of RA/QA Spire Biomedical, Inc. One Patriots Park BEDFORD MA 01730-2396 MAY - 9 2006
Re: K060155
Trade/Device Name: 15.5 Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (24cm, 28cm, 32cm, 36cm and 40cm) Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: MSD Dated: April 12, 2006 Received: April 13, 2006
Dear Mr. Fickett:
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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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.
Station of the country
4
Page 2 - Mr. Donald Fickett
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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David h. Ingram
fr
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Image /page/5/Picture/0 description: The image shows the logo for Spire Biomedical. The logo consists of the word "spire" in a bold, sans-serif font, with the word "Biomedical" written in a smaller, cursive font underneath. Above the word "spire" is a circular symbol with radiating lines, resembling a sun or starburst. The logo is black and white.
Spire Biomedical, Inc., · One Patriots Park · Bedford, MA 01730-2396 TEL (781) 275-6000 ·FAX 781 275 6010
SECTION 4 - INDICATIONS FOR INTENDED USE
510(k) Number: K060155
15.5Fr Decathlon Coated Twin Lumen Chronic Hemodialysis Device Name: Catheter with Separated Tips
Indications for Use:
Spire Biomedical Inc.'s Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic Hemodialysis and apheresis. It is a radiopaque polyurethane catheter with a heparin coating, designed for percutaneous insertion or insertion via a cutdown.
The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing.
The catheters are offered in 24cm, 28cm, 32cm, 36cm, 40cm and 55cm lengths.
Catheters longer than 40cm are intended for femoral vein insertion.
Prescription Use
and/or
Over-the-Counter Use -
(Part 21 CFR 801 Subpart D)
ﮨﮯ۔
(Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Ingram
Division Sign Off
Division Sign 510(k) Number