(82 days)
No
The summary describes a physical medical device (catheter) with a coating and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on the physical and biological properties of the catheter and its coating.
Yes
The device is designed for chronic hemodialysis and apheresis, which are therapeutic medical procedures. Its heparin coating is intended to reduce clotting, a therapeutic effect.
No.
The device is a chronic hemodialysis catheter, used for treatment (hemodialysis and apheresis), not for diagnosing a condition.
No
The device description clearly outlines a physical catheter made of radiopaque medical grade polyurethane with a heparin coating, felt cuff, and luer lock adaptors. There is no mention of software as the primary or sole component of the 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 a patient's body to filter blood.
- Device Description: The description details a catheter designed for insertion into a vein (percutaneous or cutdown). This is an invasive medical device used within the body.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests on samples.
- Performance Studies: While the performance studies include "in-vitro" tests, these tests are evaluating the properties of the catheter itself (like the heparin coating's effectiveness in reducing clotting) and not diagnosing a condition based on a patient sample.
This device is a medical device used for treatment (hemodialysis and apheresis), not an IVD used for diagnosis.
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. Catheters longer than 40cm are intended for femoral vein insertion.
Product codes
MSD
Device Description
The Decathlon™ Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis, the arterial lumen of the catheter is shorter than the catheter's distal end. The catheter has a felt cuff and dual extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Mechanical, physical, and biocompatibility tests were conducted on the predicate device. These tests were not repeated for this submission since this small change (angle between distal end lumens) does not alter any of the characteristics of the catheter. Test data from the predicate device is contained in this application.
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.
Coating bioactivity was assessed in 90-day durability tests performed on coated catheters in saline. Surface-bound heparin bioactivity (in pmol/cm') 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.
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.
Key Metrics
Reduces total thrombus accumulation by 94% (animal study) and 96% (in-vitro study), average of 96% reduction in thrombus accumulation for two hours for coated catheters (in-vitro radiolabeled measurements).
Predicate Device(s)
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.
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Image /page/0/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" in a smaller, cursive font underneath. Above the word "spire" is a circular symbol with radiating lines, resembling a sun or a star.
073093 Page 1 of 3
Spire Biomedical, Inc. One Patriots Park ↓ Bedford, MA ↓ 01730-2396 ↓USA Tel: (781) 275-6001 ↓ Fax: (781) 275-6010
510(K) SUMMARY
Decathlon Gold Kuhle Twin Lumen Chronic Hemodialysis Catheter
| Date: | September 25th, 2007 |
|---|---|
| Submitter: | Spire Biomedical, Inc. |
| One Patriots Park | |
| Bedford, MA 01730-2396 | |
| Phone: (781) 275-6000 | |
| Fax: (781) 275-6010 | |
| JAN 22 2008 | |
| Contact Person: | Raymond J Kelly IV |
| Director of RA/QA | |
| Spire Biomedical, Inc. | |
| Phone: (781) 325-0771 | |
| Fax: (781) 275-6010 | |
| E-mail: rkelly@spirecorp.com | |
| Device Names: | |
| Trade Name: | 15.5Fr Decathlon™ Gold Kuhle Twin Lumen Hemodialysis Catheter with |
| Separated Tips | |
| Common Name: | Chronic Hemodialysis Catheter |
Classification Name: Catheter, Hemodialysis, Implanted
Legally Marketed Device to Which Substantial Equivalence is Claimed:
Spire Biomedical, Inc.'s (K060155) 15.5Fr Decathlon™ Gold Twin Lumen Hemodialysis Catheter with Separated Tips (Staggered split tip configuration, twin lumen proximal end configuration including identical component clamps, luer adapters, heparin coating, and kit configuration)
Device Description: The Decathlon™ Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is constructed of radiopaque medical grade polyurethane. To reduce recirculation during hemodialysis, the arterial lumen of the catheter is shorter than the catheter's distal end. The catheter has a felt cuff and dual extension has a color coded luer lock adaptor, red for arterial and blue for venous lumen determination. Additionally, each extension has a clamp.
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Image /page/1/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" in a smaller, italicized font underneath. Above the word "spire" is a circular symbol with radiating lines, resembling a sun or a stylized flower. The entire logo is in black and white.
K073093 Page 2 of 3
Spire Biomedical, Inc. One Patriots Park ♦ Bedford, MA ♦ 01730-2396 ♦USA Tel: (781) 275-6001 ↓ Fax: (781) 275-6010
510(K) SUMMARY (CONTINUED)
Decathlon Gold Kuhle Twin Lumen Chronic Hemodialysis Catheter
Intended 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 via a cutdown. The ability of the Carmeda® End-Point Bonded heparin coating to reduce clotting is supported by in-vitro and animal testing. Catheters longer than 40cm are intended for femoral vein insertion.
Technological Characteristics Comparison to Predicate Device: The 15.5Fr Decathlon™ Gold Kuhle Twin Lumen Hemodialysis Catheter with Separated Tips is similar to the 15.5Fr Decathlon™ Gold Twin Lumen Hemodialysis Catheter with Separated Tips (K060155). It has the same polyurethane catheter body as the predicate device. The hub-lumen-extension tubes design, luer connections, kit components, packaging and sterilization, and product labeling are identical.
Additionally, the 15.5Fr Decathlor™ Gold Kuhle catheters have identical flow rates and priming volumes as compared to the 15.5Fr Decathlon™ Gold. The identical polyurethane resin is used in both the 15.5Fr Decathlon™ Gold Kuhle and 15.5Fr Decathlon™Gold.
The only difference between the proposed device and the predicate device is that the device lumens at the distal end of the device diverge at a small angle, whereas the lumens of the predicate device are substantially parallel.
Performance Data: Mechanical, physical, and biocompatibility tests were conducted on the predicate device. These tests were not repeated for this submission since this small change (angle between distal end lumens) does not alter any of the characteristics of the catheter. Test data from the predicate device is contained in this application.
Traditional Premarket Notification for Decathlon Gold Kuhle FDA Registration #: 1223643
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Image /page/2/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 a stylized sun or starburst symbol above the "i". Below "spire" is the word "Biomedical" in a cursive font. The logo is in black and white.
K073093 Page 3 of 3
Spire Biomedical, Inc. One Patriots Park + Bedford, MA + 01730-2396 + USA Tel: (781) 275-6001 ↓ Fax: (781) 275-6010
510(K) SUMMARY (CONTINUED)
Decathlon Gold Kuhle Twin Lumen Chronic Hemodialysis Catheter
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.
Coating bioactivity was assessed in 90-day durability tests performed on coated catheters in saline. Surface-bound heparin bioactivity (in pmol/cm') 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.
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.
Traditional Premarket Notification for Decathlon Gold Kuhle FDA Registration #: 1223643
5.3
Page #:
3
Public Health Service
JAN 22 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ravmond J. Kelly IV Director of Regulatory Affairs and Quality Assurance Spire Biomedical, Inc. One Patriots Park BEDFORD MA 01730-2396
Re: K073093
Trade/Device Name: 15.5Fr Decathlon™ Gold Kuhle Twin Lumen Hemodialysis Catheter with Separated Tips Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: January 10, 2008
Dear Mr. Raymond Kelly:
Received: January 11, 2008
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 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.
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Page 2 - Raymond Kelly IV
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); 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh.dsmamain.html.
Sincerely yours,
Herbert Leuner
cy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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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" in a smaller, cursive font underneath. Above the word "spire" is a circular symbol with several points radiating outward, resembling a sun or star.
Spire Biomedical, Inc. One Patriots Park + Bedford, MA + 01730-2396 +USA Tel: (781) 275-6001 + Fax: (781) 275-6010
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
15.5Fr Decathlon™ Gold Kuhle Twin Lumen Hemodialysis Catheter with Separated Tips (Lengths: 24cm, 28cm, 32cm, 36cm, 40cm, and 55cm)
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. Catheters longer than 40cm are intended for femoral vein insertion.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Hulist Lemen
(Division Sign Off)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices
Condition of CDRH, Office of Device Evaluation (ODE)
Traditional Premarket Notification for Decathlon Gold Kuhle FDA Registration #: 1223643
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