(49 days)
Not Found
No
The summary describes a physical medical device (a catheter) and its intended use and performance testing. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven analysis that would indicate the presence of AI/ML technology.
Yes
The device is a hemodialysis catheter, which is used to treat a medical condition (chronic renal failure) by performing hemodialysis, thus fitting the definition of a therapeutic device.
No
Explanation: The device is a catheter designed for chronic hemodialysis and apheresis, which are treatment procedures, not diagnostic ones. Its purpose is to facilitate blood flow for these treatments, not to identify or diagnose a condition.
No
The device description clearly identifies it as a physical catheter, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "chronic (long-term) hemodialysis and apheresis." These are medical procedures performed on a patient's body, not tests performed on samples taken from the body.
- Device Description: The description is of a physical catheter designed for insertion into a vein.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic device used for a medical treatment.
N/A
Intended Use / Indications for Use
The 55cm 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. Catheters longer than 40cm are intended for femoral vein insertion.
Product codes
78 MSD
Device Description
55cm 15.5Fr Decathlon™ carbothane Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.
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
A series of mechanical and physical tests, including tensile and flow, were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters.
Key Metrics
Not Found
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.
0
06 1.2
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 with multiple petals or rays emanating from the center.
Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-6010 fax
: 2004 DEC
Section 7 510(k) Summary 55cm 15.5Fr Decathlon
- October 14, 2004 Date:
- Spire Biomedical, Inc. Submitter: 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: | 55cm 15.5Fr Decathlon |
|---|---|
| Common Name: | Long Term Hemodialysis catheter |
| Classification Name: | Chronic Hemodialysis Catheter |
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
-
- Spire Biomedical, Inc. 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips "K032061."
Device Description: 55cm 15.5Fr Decathlon™ carbothane Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.
- Spire Biomedical, Inc. 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips "K032061."
1
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 symbol with several points radiating outward, resembling a sun or a stylized flower.
Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-6010 fax
510(k) Summary (Continued)
55cm 15.5Fr Decathlon™ Catheter Kit
Intended Use: The 55cm 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.
Catheters longer than 40cm are intended for femoral vein insertion.
Technological Characteristics Comparison to Predicate Devices: The 55cm 15.5Fr Decathlon™ catheter uses the exact same materials of construction.
Performance Data: A series of mechanical and physical tests, including tensile and flow, were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2004
Donald D. Fickett, Jr., CQE Director of RA/QA Spire Corporation One Patriots Park BEDFORD MA 01730-2396
Re: K042858
R042030
Trade/Device Name: 55cm 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Catheter with Separated Tips Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: 78 MSD Dated: November 29, 2004 Received: December 1, 2004
Dear Mr. Fickett:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 for use suited in the May 28, 1976, the enactment date of the Medical Device Amendments or to conninered pror contral 2011a) 2011-12-11 accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls and Occirce 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 ass we confication 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) parenase Jobmit a new 510(k) before including these components in your kit. The general you mast basiness 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.
3
Page 2 – Mr. Donald Fickett, Jr.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuality of a subscuration with other requirements of the Act
that FDA has made a determination that your device of a forely of any must that FDA has made a decemmation that your certed by other federal agencies. You must and or any Federal statutes and regulations as annualing, but not limited to: registration (2) CFR Part
comply with all the Act's requirements, including, but not limited to: pr comply with all the Act s requirements, molumb, world 801); good manufacturing practice
807); listing (21 CFR Part 807), labeling (21 CFR Part 801 (CFR Part 820); and if 807); insting (21 CFR 1 art 807); laboling (21 CFR Part 820); and if requirements as set form in the quality systems (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) I his letter will anow you to begin manceling your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of this premarket notification. The I DA midnig of bativation for your device and thus, permits your marketed predicate device results in a classified with your device on the labeling.
device to proceed to the market. If you desire specific advice on the label pate the device to proceed to the market. In you desire specific (20)276-0115. Also, please note the regulation, please contact the Orited of Complanes an an and its ation' (21 CFR Part 807.97).
regulation entitled, "Misbranding by reference to premarket notification" (21 CF regulation entitled, "Misolanding by reicent for responsibilities under the Act from the You may other general mionmation on your respectiver 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 yours,
Nancy C. Burgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
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 starburst.
Spire Biomedical, Inc. • One Patriots Park • Bedford, MA 01730-2396 (781) 275-6001 • (781) 275-6010 fax
APPENDIX B - Indications for Use Statement
- 55cm 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis Device Name: Catheter with Separated Tips
- Indications for Use: The 55cm 15.5Fr Decathlon Twin Lumen Chronic Hemodialysis The ooom 10.0.11 Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
Catheters longer than 40cm are intended for femoral vein insertion.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
Prescription Use
Nancy Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number JMS K04285
37