(173 days)
Not Found
No
The 510(k) summary describes a physical medical device (a hemodialysis catheter) and its materials and performance characteristics. There is no mention of software, algorithms, or any technology that would typically incorporate AI or ML.
Yes
The device is designed for chronic (long-term) hemodialysis and apheresis, which are medical procedures used to treat illnesses by removing harmful substances from the blood.
No
This device is a catheter designed for hemodialysis and apheresis, which are treatment procedures, not for diagnosing conditions.
No
The device description clearly details a physical catheter made of polyurethane and silicone, with specific dimensions and materials. There is no mention of software as the primary component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "chronic (long-term) hemodialysis and apheresis," which are medical procedures performed on a patient's body. IVDs are used to examine specimens from the body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a catheter designed for insertion into a vein. This is an invasive medical device, not a diagnostic test performed on a sample.
- No mention of analyzing samples: The text focuses on the physical characteristics and performance of the catheter itself, not on any process of analyzing biological samples.
Therefore, this device is a medical device used for treatment (hemodialysis and apheresis), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use of the 15.5Fr "Decathlon" catheters are identical to the Pourchez XpressO™ Twin Lumen Chronic Hemodialysis catheter with Separated Tips. The 15.5Fr "Decathlon" is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion via cutdown into the jugular or subclavian vein. The 15.5Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
Product codes (comma separated list FDA assigned to the subject device)
78 MSD
Device Description
The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Pourchez XpressO™ flexible radiopaque silicone catheters and supplements our Pourchez XpressO catheter line by offering a polyurethane catheter with similar tip-to-hub length catheters of 24cm, 28cm, 32cm, 36cm & 40cm. The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter's split tip design (with the exception of the polyurethane catheter body, clear urethane tubing, urethane hub and cross-sectional profile) are identical to our silicone Pourchez XpressO™ catheters listed within our 510(K) Premarket Notification Submission (K013160). The round outer profile with semi-circular cross-sectional lumens is similar to the MedComp Ash Split Cath™ The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix (Appendix (G). Optional use of polyvinyl chloride luer adapters has also been qualified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
jugular or subclavian 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)
15.5Fr "Decathlon" catheters have similar product performance flow rates and priming volumes as compared to our silicone Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips. The polyurethane resin is similar to the Kendall Maxid catheter. A series of mechanical and physical tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters. In all cases, the 15.5Fr "Decathlon" catheter demonstrated equivalent or better performance to the predicate devices and/or exceeded the minimum acceptance criteria established by the appropriate standard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
K03206/
Figs 1 of 2
Image /page/0/Picture/2 description: The image shows the logo for Spire Biomedical. The word "spire" is in bold, black, sans-serif font. Above the "i" in "spire" is a black circle with spikes coming out of it. Below "spire" is the word "Biomedical" in a cursive font.
DEC 2 3 2003
Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-6010 fax
SECTION 7
510(K) SUMMARY
15.5Fr Polyurethane "Decathlon" Twin Lumen Chronic Hemodialysis Catheter
Date: July 2, 2003
Submitter: Spire Biomedical, Inc. One Patriots Park Bedford, MA 01730-2396 Phone: (781) 275-6001 Fax: (781) 275-6010
- Contact Person: Donald Fickett Director of RA/QA Spire Biomedical, Inc. Phone: (781) 275-6001 x221 Fax: (781) 275-6010 e-mail: dfickett@spirecorp.com
Device Names:
| Trade Name: | 15.5Fr “Decathlon” Twin Lumen Chronic Hemodialysis Catheters |
|---|---|
| Common Name: | Catheter, Intravascular, Long-Term |
| Classification Name: | Catheter, Hemodialysis, Implant (Long-Term) |
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
-
- Spire Biomedical, Inc.'s Pourchez XpressO™ (Split tip distal end, twin lumen proximal end configuration including identical component clamps, luer adapters, product performance and same indication for use)
-
- Medical Components, Inc. Ash Split Cath™ (round outer profile with semi-circular cross-sectional lumens)
-
- Kendall Healthcare Maxid™ (same polyurethane material for catheter body, hub and tubing)
Device Description: The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter is a product line extension of Spire Biomedical, Inc.'s Pourchez XpressO™ flexible radiopaque silicone catheters and supplements our Pourchez XpressO catheter line by offering a polyurethane catheter with similar tip-to-hub length catheters of 24cm, 28cm, 32cm, 36cm & 40cm.
1
KC32061
Page 2 of 2
Image /page/1/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 symbol that resembles a sun or starburst, with multiple rays or points emanating from a central circle. The entire logo is in black and white.
Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-6010 fax
510(K) Summary (Continued)
15.5Fr Polyurethane "Decathlon" Twin Lumen Chronic Hemodialysis Catheter
Intended Use: The indications for use of the 15.5Fr "Decathlon" catheters are identical to the Pourchez XpressO™ Twin Lumen Chronic Hemodialysis catheter with Separated Tips. The 15.5Fr "Decathlon" is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion via cutdown into the jugular or subclavian vein.
Technological Characteristics Comparison to Predicate Devices: The 15.5Fr "Decathlon" Twin Lumen Chronic Hemodialysis Catheter's split tip design (with the exception of the polyurethane catheter body, clear urethane tubing, urethane hub and cross-sectional profile) are identical to our silicone Pourchez XpressO™ catheters listed within our 510(K) Premarket Notification Submission (K013160). The round outer profile with semi-circular cross-sectional lumens is similar to the MedComp Ash Split Cath™ The polyurethane catheter body material is identical to that used in the Kendall Healthcare Maxid™ catheter, as verified by an IR Scan analysis (Appendix (Appendix (G). Optional use of polyvinyl chloride luer adapters has also been qualified.
Selected biocompatibility testing was conducted on the catheter and carbothane resin. Results are provided in Appendix B.
Performance Data: 15.5Fr "Decathlon" catheters have similar product performance flow rates and priming volumes as compared to our silicone Pourchez XpressO™ Twin Lumen Chronic Hemodialysis Catheters with Separated Tips. The polyurethane resin is similar to the Kendall Maxid catheter. A series of mechanical and physical tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters. In all cases, the 15.5Fr "Decathlon" catheter demonstrated equivalent or better performance to the predicate devices and/or exceeded the minimum acceptance criteria established by the appropriate standard.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2003
Mr. Donald Fickett Director of RA/QA Spire Biomedical, Inc. One Patriots Park BEDFORD MA 01730-2396
Re: K032061
Trade/Device Name: 15.5Fr Polyurethanc "Decathlon" Twin Lumen Chronic Hemodialysis Catheter; 24cm, 28cm, 32cm, 36cm and 40cm Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: September 29, 2003 Received: October 6, 2003
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.
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
3
Page 2 - Mr. Donald Fickett
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 (301) 594-4616. 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/dsma/dsmamain.html.
Sincerely vours.
David A. Segarm
for
Nancy C. Brogdor Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO32061
Image /page/4/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 symbol that resembles a stylized sun or asterisk with multiple points radiating outward.
Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-6010 fax
APPENDIX B - Indications for Use Statement
Device Name: 15.5 Fr. Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (24cm, 28cm, 32cm, 36cm & 40cm)
The 15.5Fr. Decathlon Twin Lumen Chronic Hemodialysis Indications for Use: Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniela Leggmm
(Optional Format 3-10-98)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: 032061
Prescription Use