(105 days)
No
The document describes a physical medical device (a catheter) and its intended use and performance testing. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML.
Yes
The device is a catheter used for hemodialysis and apheresis, which are medical treatments aimed at therapeutic outcomes for patients requiring long-term vascular access, thus qualifying it as a therapeutic device.
No
The device description and intended use state that it is a catheter for attaining vascular access for hemodialysis and apheresis, which are treatment procedures, not diagnostic ones.
No
The device description clearly describes a physical catheter and associated components, not software.
Based on the provided text, the Arrow NextStep® Retrograde Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "attaining long-term vascular access for hemodialysis and apheresis." This involves accessing the patient's bloodstream directly for treatment, not for testing samples of blood or other bodily fluids outside the body.
- Device Description: The description details a catheter designed for insertion into veins to provide access to the central venous system. This is a medical device used in vivo (within the living body).
- Lack of IVD Characteristics: The text does not mention any components or functions related to analyzing samples, reagents, or diagnostic testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The Arrow NextStep Retrograde Catheter is a therapeutic device used for direct patient treatment.
N/A
Intended Use / Indications for Use
The Arrow NextStep® Retrograde Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep Retrograde Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow NextStep Retrograde catheter is intended for use in adult patients.
Product codes
MSD
Device Description
The NextStep Retrograde Chronic Hemodialysis Catheter (herein referred to as the proposed NSR catheter) is a long-term, single use catheter designed to provide access to the central venous system in a healthcare facility environment. The catheter is a two-piece, two-lumen, 15 Fr, step-tipped catheter designed for retrograde placement. The catheter is available in multiple lengths.
The catheters will be packaged sterile with various components to facilitate insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
internal jugular (IJ) vein, subclavian vein, femoral vein
Indicated Patient Age Range
adult patients
Intended User / Care Setting
healthcare facility environment
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
Nonclinical Testing: The dialysis flow rate, hemolysis, and additional testing that is needed to comply with Draft Guidance for Industry and Food and Drug Administration Staff- Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis was performed for the longer length catheters. Bench testing was previously completed on the predicate NextStep Retrograde catheters in accordance with ISO 10555-1 and 10555-3. Testing included biocompatibility (ISO 10993-1).
Key Metrics
Not Found
Predicate Device(s)
Arrow NextStep Antegrade Chronic Hemodialysis Catheter (K111900), Arrow NextStep Retrograde Chronic Hemodialysis Catheter (K111117)
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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K130192
Page 1 of 2
MAY 1 0 2013
510(k) SUMMARY
SUMMARY OF SAFETY AND EFFECTIVENESS FOR
NextStep Retrograde Catheters with Expanded Indications and Increased Lengths
1. Submitter Information
| Name: | Arrow International, Inc (subsidiary of Teleflex Inc.) |
|---|---|
| Address: | 2400 Bernville Road |
| Reading, PA 19605-9607 | |
| Telephone Number: | (610) 378-0131 |
| Contact Person: | Gwen Taschner |
| Regulatory Affairs Associate | |
| Telephone Number: | (610) 378-0131 Extension 603253 |
| Fax Number: | (610) 478-3179 |
| Email: | gwen.taschner@teleflex.com |
January 31, 2013 Date Prepared:
2. Device Name
Device Trade Name: NextStep Retrograde Chronic Hemodialysis Catheter Common Name: Classification Name: Catheter, Hemodialysis, Implanted
3. Predicate Devices
Predicate 1: Arrow NextStep Antegrade Chronic Hemodialysis Catheter (K111900) Predicate 2: Arrow NextStep Retrograde Chronic Hemodialysis Catheter (K111117)
4. Device Description
The NextStep Retrograde Chronic Hemodialysis Catheter (herein referred to as the proposed NSR catheter) is a long-term, single use catheter designed to provide access to the central venous system in a healthcare facility environment. The catheter is a two-piece, two-lumen, 15 Fr, step-tipped catheter designed for retrograde placement. The catheter is available in multiple lengths.
The catheters will be packaged sterile with various components to facilitate insertion.
5. Indications for Use
The Arrow NextStep® Retrograde Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep Retrograde Catheter is inserted percutaneously and is preferentially placed into the internal jugular (IJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are
1
intended for femoral vein insertion. The Arrow NextStep Retrograde catheter is intended for use in adult patients.
6. Technological Characteristics and Substantial Equivalence
The NextStep Retrograde catheter with expanded indications to add femoral indications and increased lengths is substantially equivalent to the Arrow NextStep Antegrade Chronic Hemodialysis Catheters (K111900) and the Arrow NextStep Retrograde Chronic Hemodialysis Catheter (K111117) in terms of overall design, manufacturing process, functional performance, and materials of construction. The indications for use, for the proposed catheter, are identical to the Arrow NextStep Antegrade Chronic Hemodialysis Catheter (long-term vascular access for hemodialysis and apheresis, placed in the internal jugular, subclavian or femoral veins). The intended use of the product and the principle of operation of the device is unchanged.
7. Nonclinical Testing
The dialysis flow rate, hemolysis, and additional testing that is needed to comply with Draft Guidance for Industry and Food and Drug Administration Staff- Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis was performed for the longer length catheters. Bench testing was previously completed on the predicate NextStep Retrograde catheters in accordance with ISO 10555-1 and 10555-3. Testing included biocompatibility (ISO 10993-1).
8. Clinical Data
Clinical performance data was not used to determine substantial equivalence.
9. Conclusions
The results of the testing performed have demonstrated that the proposed NSR catheters are safe and perform as intended and therefore are considered substantially equivalent to the cited predicate devices.
10. Necessary Information
At this time the 510k Summary includes the information deemed necessary by FDA.
11. The following information has been met:
- The summary includes only information that is covered in the body of the . 510(k).
- The summary does not contain any puffery or unsubstantiated labeling claims. .
- The summary does not contain any raw data. .
- The summary does not contain any trade secret or confidential commercial . information.
- The summary does not contain any patient identification information. .
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 10, 2013
Arrow International, Inc. % Ms. Gwen Taschner Regulatory Affairs Specialist 2400 Bernville Road READING PA 19605
- Re: K130192
Trade/Device Name: Arrow NextStep® Retrograde Chronic Hemodialysis Catheter Regulation Number: 21 CFR§ 876.5540 Regulation Name: Blood access device and accessories Regulatory Class: III Product Code: MSD Dated: April 9, 2013 Received: April 12, 2013
Dear Ms. Taschner:
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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
3
Page 2 - Ms. Gwen Taschner
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 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): _ K130192
Device Name: Arrow NextStep® Retrograde Chronic Hemodialysis Catheter
Indications for Use:
The Arrow NextStep® Retrograde Catheter is indicated for use in attaining long-term vascular access for hemodialysis and apheresis. The Arrow NextStep Retrograde Catheter is inserted percutaneously and is preferentially placed into the internal jugular (JJ) vein. Alternately, this catheter may be inserted into the subclavian vein although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Arrow NextStep Retrograde catheter is intended for use in adult patients.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P. Lerner -S
Page 1 of 1
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130192 510(k) Number