(77 days)
No
The summary describes a physical medical device (a catheter) with a heparin coating to reduce clotting. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
No
The device is a chronic hemodialysis catheter, which is used for accessing the bloodstream during dialysis, a life-sustaining treatment, but the catheter itself is not directly therapeutic; it's an accessory to the therapeutic process.
No
This device is a chronic hemodialysis catheter, designed to facilitate treatment, not to diagnose a condition.
No
The device description clearly details a physical catheter made of polyurethane with a heparin coating, designed for insertion into the body. It is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "chronic hemodialysis and apheresis." These are procedures performed directly on the patient's body to filter blood or remove specific components.
- Device Description: The description details a catheter designed for insertion into a blood vessel (femoral vein) to facilitate these procedures.
- Performance Studies: The performance studies mentioned are "In-vitro blood loop testing" and "Catheter flows (bench testing)." While these involve testing with blood outside the body, the purpose is to evaluate the performance of the catheter itself in a simulated environment, not to diagnose a condition in a patient.
- Lack of Diagnostic Purpose: There is no mention of this device being used to analyze samples (blood, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for medical purposes. This device is used in vivo (inside the body) for therapeutic procedures.
N/A
Intended Use / Indications for Use
Spire Biomedical Inc's Decathlon Gold, Coated Twin Lumen Indications for Use: Chronic Hemodialysis Catheter with separated funnel tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda® End point Bonded Heparin Coating to reduce clotting is supported by invitro testing. Catheters longer than 40cm are intended for femoral vein insertion.
Product codes
78 MSD
Device Description
Spire Biomedical, Inc.'s 15.5Fr Decathlon Gold, Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Gold. Coated catheters are fully coated with CBAS® on the internal surface and on the 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 distal ends of this catheter have the arterial and venous tips rounded and "funneled" for easier over the wire insertion. It has one elliptical side hole placed on the distal ends of the arterial and venous lumens. A stylet will be preloaded in the arterial lumen for ease of guidewire placement.
The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiopaque
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Two hour In-vitro blood loop testing. .
Catheter flows (bench testing)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
End-point thrombus radiolabeled measurements showed an average of 51% reduction in thrombus accumulation for two hours for coated catheters.
Predicate Device(s)
Reference Device(s)
K925626, K933586, K970906, P900043/S024
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
Page 1 of 3
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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
'JAN 公 9 2007
15.5Fr Decathlon Gold, Coated Catheters with funnel tips
Date: November 2, 2006
- Submitter: Spire Biomedical, Inc. One Patriots Park Bedford, MA 01730-2396 Phone: (781) 275-6000 Fax: (781) 275-7470
Contact Person: Shekhar Nimkar Director of Product Development and Manufacturing Spire Biomedical, Inc. Phone: (781) 275-6001 x203 Fax: (781) 275-6010 email: snimkar@spirecorp.com
Device Names:
| Trade Name: | 15.5Fr Decathlon Gold, Coated Catheters with funnel tips |
|---|---|
| Common Name: | Catheter, Intravascular, Long-Term |
| Classification Name: | Catheter, Hemodialysis, Implant (Long-Term) |
| Classification: | Class III |
| Device Code: | 78 MSD |
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K063431 Page 2 of 3
Image /page/1/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, cursive font underneath. Above the word "spire" is a circular shape with several triangular points radiating outward, resembling a sun or a stylized flower. The entire logo is in black and white.
Spire Biomedical, Inc., · One Patriots Park · Bedford, MA 01730-2396 TEL (781) 275-6000 •FAX 781 275 6010
510(k) Summary (Continued)
Device Description:
Spire Biomedical, Inc.'s 15.5Fr Decathlon Gold, Coated catheters are processed with a proprietary Carmeda® BioActive Surface (CBAS®) coating technology that attaches a functionally active heparin to the surfaces of the coating counteracts thrombus from forming on the catheter. Spire's 15.5Fr Decathlon Gold. Coated catheters are fully coated with CBAS® on the internal surface and on the 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 distal ends of this catheter have the arterial and venous tips rounded and "funneled" for easier over the wire insertion. It has one elliptical side hole placed on the distal ends of the arterial and venous lumens. A stylet will be preloaded in the arterial lumen for ease of guidewire placement.
The coating is essentially non-leaching. Additionally, the maximum amount of heparin on the surface is only 1mg. Therefore; the effects of the entire coating on a patient's coagulation status would be insignificant.
Product Claims:
As demonstrated in two in-vitro study, 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 seven regular intervals. Heparin bioactivity remained essentially constant throughout the test period, demonstrating that the coating's bioactive properties were maintained.
In-vitro studies have demonstrated that the coating reduces total thrombus accumulation by 51% 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 was circulated through the catheter at a constant flow rate. Three criteria were 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 Gold, coated catheters with funnel tips vs. uncoated catheters. End-point thrombus radiolabeled measurements showed an average of 51% reduction in thrombus accumulation for two hours for coated catheters.
" Data on file
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Page 3 of 3
Image /page/2/Picture/2 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, cursive font underneath. Above the word "spire" is a circular symbol with several points radiating outward from the center, resembling a sun or a star.
Spire Biomedical, Inc., · One Patriots Park · Bedford, MA 01730-2396 TEL (781) 275-6000 •FAX 781 275 6010
Technological Characteristics Comparison to Predicate Devices:
The 15.5Fr Decathlon Gold, coated catheter with funnel tips is identical to the Coated Decathlon catheter (K060155) in physical characteristics, namely, materials of construction, dimensions, and the coating. The only difference is the distal tips, which are funneled for easier over the wire insertions.
The Carmeda® BioActive Surface (CBAS®) coating has been approved for the following legally marketed devices to which substantial equivalence is claimed:
-
- Spire Biomedical coated Decathlon (K060155)
- లో Diametrics Paratrend intravascular blood gas sensor catheter (K970906)
-
- Cordis Bx Velocity coronary stent (P900043/S024)
Performance Data:
The data from the coated Decathlon (K060155) were not duplicated for the Decathlon Gold with funnel tips since the materials of construction, the dimensions, and the coating are identical to the coated Decathlon with the exception of the distal arterial and venous tips. The following tests were conducted on the predicate device but are not repeated here:
- . Stability (leaching) for 90 days
- Durability testing (Accelerated aging for one year) .
- Mechanical properties (Tensile strength)
The following additional tests were conducted on the Decathlon Gold catheters with funnel tips to demonstrate coating performance claims:
- Two hour In-vitro blood loop testing. .
- Catheter flows (bench testing)
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Shekhar Nimkar Director of Product Development and Manufacturing Spire Biomedical, Inc. One Patriots Park BEDFORD MA 01730-2396
JAN 2 9 2007
Re: K063431
Trade/Device Name: 15.5Fr Decathlon Gold, Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Funnel Tips
Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: November 2, 2006 Received: November 13, 2006
Dear Mr. Nimkar:
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.
4
Page 2 – Mr. Shekhar Nimkar
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,
Daniel C. Lyman
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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 (if known)
Device Name:
15.5Fr Decathlon Gold, Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Funnel Tips
Spire Biomedical Inc's Decathlon Gold, Coated Twin Lumen Indications for Use: Chronic Hemodialysis Catheter with separated funnel tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda® End point Bonded Heparin Coating to reduce clotting is supported by invitro testing. Catheters longer than 40cm are intended for femoral vein insertion.
Prescription Use V (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use
(Part 21 CFR 801 Subpart C)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K063431
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)