(291 days)
JMS Safe Wing Cath (SWC) is intended for short-term (less than 30 days) access to patient's vascular system for intravascular fluid administration and to sample blood, and to monitor blood pressure. The device is intended for single use only and has an anti-stick feature integrated which aids in prevention of needle-stick injuries.
JMS Safe Wing Cath (SWC) is a single lumen intravenous catheter device for vascular access incorporating an anti-needle stick safety feature. The anti-needle stick feature is integrated in the Safe Wing Cath (SWC) body and functions during retraction of the needle, after vascular access is accomplished (there is a stopper to prevent unwanted retraction of needle during insertion). During retraction, the needle will slide into the body and will lock at the final locking position. An audible clicking sound is heard or locking force is felt when the needle is fully retracted into the final locking position. The entire needle is encapsulated within the body and prevents needle-stick injuries, while the catheter still has vascular access for intravenous fluid administration.
The JMS Safe Wing Cath (SWC) device is an intravascular catheter with an anti-needle stick safety feature. The study conducted to demonstrate its performance and substantial equivalence to predicate devices involved multiple types of tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria (Implicit from Predicate Comparison or ISO Compliance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Pass ISO 10993 standards | All tests passed (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Subchronic Toxicity, Genotoxicity, Implantation, Hemocompatibility) |
| Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶ (ANSI/AAMI/ISO 11135) | Passed, validated to 10⁻⁶ SAL |
| Residual EO ≤ 4 mg/device; Residual ECH ≤ 9 mg/device (ANSI/AAMI/ISO 10993-7) | Met requirements for limited exposure devices | |
| ISO 10555-1 Compliance | Conformance to ISO 10555-1 standards for intravascular catheters | All specified tests passed (Surface inspection, Corrosion resistance, Force at break, Freedom from leakage (Positive pressure), Air leakage during aspiration, Flow rate, Catheter under X-Ray, Strength of Union Hub and Needle tube, Leakage Needle hub/Tubing/Female Connector) |
| Simulated Use Performance | 100% success with no device failures and devices performing as intended | 100% success on over 500 samples |
| Comparison to Predicate (Performance Bench Testing) | No significant difference compared to predicate device (BD Nexiva™ Closed IV Catheter System) | No significant difference reported for: - Catheter (Elastic Modulus in Tension, Tensile Strength, Tensile Elongation) - Catheter Flexural Modulus - Force Break of Tubing and Female Connector - Force Break of tubing to needle hub - Force Break needle and needle hub - Catheter collapse Pressure test |
| Determination of: | Pressure determined for maximum positive pressure Volumes determined for priming volume |
2. Sample Size Used for the Test Set and Data Provenance
- Simulated Clinical Use Test: "over 500 samples" of the device were tested.
- Predicate Comparison Bench Testing: The specific sample sizes for each mechanical and flow test are not explicitly stated, but the results indicate that a sufficient number were tested to determine statistical significance or lack thereof.
- Data Provenance: The simulated clinical use test involved "43 healthcare workers from the Washington/Baltimore area," suggesting a prospective clinical simulation within the USA. The bench testing data would be internal laboratory data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Simulated Clinical Use Test: "43 healthcare workers" were involved. Their specific qualifications (e.g., years of experience, specialty) are not detailed in the provided summary, but they are described as "healthcare workers," implying relevant professional experience in using such devices.
- Bench Testing: For the in-house bench testing comparing to the predicate, the "ground truth" is established through standardized laboratory test methods (e.g., ISO 10555-1, JIS T3223:2011). No "experts" in the human assessment sense are required to establish this type of ground truth; rather, the tests are performed by qualified laboratory personnel following validated protocols.
4. Adjudication Method for the Test Set
- Simulated Clinical Use Test: The text states "100% success with no device failures and all devices performing as intended." This implies a binary assessment of success or failure for each device, likely without complex adjudication, as any failure would presumably disqualify it from the "100% success" claim.
- Bench Testing: For the laboratory tests, the "adjudication" is based on meeting the defined parameters of the standard test methods or demonstrating statistical equivalence to the predicate device. This is an objective measurement rather than a consensus-based adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This type of study is typically associated with diagnostic imaging devices where multiple human readers assess cases with and without AI assistance. The JMS Safe Wing Cath is a medical device for vascular access, and its evaluation focuses on physical performance, safety features, and clinical usability rather than diagnostic accuracy.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This device does not involve an algorithm or AI. Its performance is entirely device-centric (e.g., mechanical properties, flow rates, safety mechanism function), and its evaluation is based on bench testing and simulated clinical use involving human interaction with the physical device. Therefore, a standalone algorithm-only study is not applicable.
7. Type of Ground Truth Used
- Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and passing specified biological tests.
- Sterilization: Ground truth is established by achieving a validated Sterility Assurance Level (SAL) and meeting residual chemical limits.
- ISO 10555-1 Compliance: Ground truth is defined by the passing criteria of the specific ISO 10555-1 test methods.
- Simulated Use: Ground truth is based on functional performance during simulated clinical scenarios, assessed by healthcare workers, with the criterion being "performing as intended" and "no device failures."
- Predicate Comparison Bench Testing: Ground truth is the measured performance of both the JMS Safe Wing Cath and the predicate device, with the acceptance criterion being "no significant difference" between the two.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development and testing are based on engineering principles, materials science, and medical device standards.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
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510(k) Summary
807.92(c)
MAR 0 5 2013
807.92(a)(1) SPONSOR JMS North America Corp. Company Name: 22320 Foothill Blvd., Suite 350 Company Address Hayward, CA 94541 510-888-9090 Telephone: 510-888-9099 Fax: Contact Person: Sho Hosoki
Summary Preparation Date: April 9, 2012
DFVICF NAME
| DEVICE NAME | 807.92(a)(2) |
|---|---|
| Trade Name: | JMS Safe Wing Cath (SWC) |
| Common/Usual Name: | Intravascular Catheter |
| Classification Name: | Intravascular Catheter |
| Regulation Number: | 21 CFR 880.5200 |
| Product Code: | FOZ |
| Device Class: | Class II |
PREDICATE DEVICE
807.92(a)(3)
Legally Marketed Equivalent Devices
| K Number | Product | Company |
|---|---|---|
| K102520 | BD Nexiva™ Closed IV Catheter System | Dickinson Infusion TherapySystems, Inc. |
| K895481 | SHAMROCK Winged Needle Infusion Set | Smiths Medical |
| K110157 | SysLoc Mini V3 | JMS Singapore Pte Ltd |
DEVICE DESCRIPTION
807.92(a)(4)
JMS Safe Wing Cath (SWC) is a single lumen intravenous catheter device for vascular access incorporating an anti-needle stick safety feature. The anti-needle stick feature is integrated in the Safe Wing Cath (SWC) body and functions during retraction of the needle, after vascular access is accomplished (there is a stopper to prevent unwanted retraction of needle during insertion). During retraction, the needle will slide into the body and will lock at the final locking position. An audible clicking sound is heard or locking force is felt when the needle is fully retracted into the final locking position. The entire needle is encapsulated within the body and prevents needle-stick injuries, while the catheter still has vascular access for intravenous fluid administration.
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DEVICE INTENDED USE
807.92(a)(5)
JMS Safe Wing Cath (SWC) is intended for short-term (less than 30 days) access to patient's vascular system for intravascular fluid administration and to sample blood, and to monitor blood pressure. The device is intended for single use only and has an anti-stick feature integrated which aids in prevention of needle-stick injuries.
| Device | Modified Device | Currently Legally Marketed Predicate Device (Predicate 1) |
|---|---|---|
| Manufacture | JMS Safe Wing Cath (SWC)JMS Japan | BD Nexiva Closed IV Catheter SystemBecton, Dickinson and Company |
| 510(K) # | --- | K102520 |
| Classification | Class II | Class II |
| Intended Use | JMS Safe Wing Cath (SWC) isintended for short-term (less than30 days) access to patient's vascularsystem for intravascular fluidadministration, to sample blood,and to monitor blood pressure. Thedevice is intended for single useonly and has an anti-stick featureintegrated which aids in preventionof needle-stick injuries. | The NexivaTM4 intravascular catheter isinserted into a patient's vascular systemfor a short-term use (less than 30 days) tosample blood, monitor blood pressure, oradminister fluids intravascularly. Theneedle-shielding feature and luer accessport, aid in the prevention of needle-stickinjuries. Blood is contained within thedevice during the catheter insertionprocess aiding in the prevention of bloodexposure. This catheter may be used forany patient population with considerationgiven to adequacy of vascular anatomyand appropriateness of procedure.The 18-22 gauge NexivaTM catheters aresuitable for use with power injectors ratedfor a maximum of 300 psi when the lueraccess port(s) is removed and a directconnection is made. |
| Catheter ID (mm) | 20G: 0.8 (0.7 ~ 0.9)22G: 0.6 (0.5 ~ 0.7)24G: 0.5 (0.4 ~ 0.6) | 20G: 0.8322G: 0.6724G: 0.53 |
| Catheter OD (mm) | 20G: 1.1 (0.950 ~ 1.149)22G: 0.9 (0.750 ~ 0.949)24G: 0.7 0.650 ~ 0.749) | 20G: 1.1022G: 0.9024G: 0.71 |
| Length of ExposedCatheter | All gauges: 19.0 (±8%) mm0.76 Inches | 20G: 1.00, 1.25, or 1.75 Inches22G: 1.00 Inches24G: 0.56 or 0.75 Inches |
| Number of Lumens | 1 | 1 |
| Distal End Configuration | Needle and catheter | Needle and catheter |
| Intended AnatomicalLocation of Distal End | Peripherals | Peripherals |
| Proximal EndConfiguration | Luer Lock | 2 ports: Luer Access Split Septum & VentPlug |
| Water Flow Rate | 20G: 38 | 20G: 1.00 catheter length: 54 |
| (mL/min) | 22G: 2824G: 16 | 22G: 1.00 catheter length: 2724G: 0.75 catheter length: 13 |
| Catheter Body TensileStrength | 20G: 29.3N22G: 21.5 N24G: 14.3N | 20G: 28.6 N22G: 21.6 N24G: 12.8 N |
| Catheter to Catheter HubStrength | 20G: 19.9N22G: 14.7N24G: 12.6N | 20G: 19.3N22G: 15.4N24G: 9.7N |
| Catheter Stiffness (ElasticModulus) | 20G: 487.9 MPa22G: 440.7 MPa24G: 401.0 MPa | 20G: 487.9 MPa22G: 405.8 MPa24G: 423.0 MPa |
| Catheter TensileElongation | 20G: 951.6%22G: 717.7%24G: 779.4% | 20G: 815.0%22G: 772.8%24G: 453.6% |
| Flexural Modulus | 22G: 734.3 MPa | 22G: 582 MPa |
| Tubing to Hub TensileStrength | 20G: 35.4N22G: 32.9N24G: 34.5N | 20G: 56.6N22G: 46.7N24G: 42.1N |
| Tubing to FemaleConnector TensileStrength | Same for All Gauges: 32.2N | 20G: 65.6N22G: 51.8N24G: 42.0N |
| Needle to Need HubStrength | 20G: 128.4N22G: 92.3N24G: 72.4N | 20G: 118.8N22G: 66.5N24G: 38.2N |
| Leakage at Hub | None (at 150kPA for 15min) | None |
| Catheter Burst Pressure | 22G: 2.22MPa | 22G: 2.66MPa24G: 2.84MPa |
| Catheter CollapsePressure | Tested up to -99.3MPa with noleakage | Tested up to -99.3MPa with no leakage |
| Open or Closed System | Closed System | Closed System |
| Labels | Similar to Predicate(Refer toSection 13) | Refer to Section 13 |
comparison of technical Characteristics 807.92(a)(6)
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Side by Side Comparison of Substantial Equivalent Appearance and Safety Feature, with Legally Marketed Device with Comparable Patient Exposure
Please note that the predicate 2 does not have a catheter, but has substantial equivalence with the JMS SWC due to its appearance, safety mechanism feature, and intended use. Please consider JMS SWC device as a modification of predicate 2 with a catheter, in which has substantial equivalence to predicate 1. Also, please note that SysLoc Mini v3 is a legally marketed device with comparable patient exposure and this device is used to show material biocompatibility in section 15.
| Device | Modified Device | Legally Marketed Predicate Device(Predicate 2) | Legally Marked Devicewith Comparable PatientExposure |
|---|---|---|---|
| JMS Safe Wing Cath(SWC) | SHAMROCK Winged NeedleInfusion Set | SysLoc Mini V3 | |
| Manufacture | JMS Japan | Smiths Medical ( JMS Singapore PteLtd provide unfinished medicaldevice) | JMS Singapore Pte Ltd |
| 510(K) # | --- | K895481 | K110157 |
| Classification | Class II | Class II | Class II |
| Intended Use | JMS Safe Wing Cath | This device is used by the healthcare | SysLoc@ MINI( V3) is |
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| (SWC) is intended forshort-term (less than 30days) access to patient'svascular system forintravascular fluidadministration, tosample blood, and tomonitor blood pressure.The device is intendedfor single use only andhas an anti-stick featureintegrated which aids inprevention of needle-stick injuries. | professional to administer I.V. fluidsto a patient. The materials used in themanufacture of this device (SeeExhibit VIII) are comparable tosimilar on the market. The parallel ofsimilar materials from this device toexisting devices will allow thehealthcare worker to administer thesame I.V. fluids which are currentlybeing administered. The uniquenessof the device of this submission liesin the ability of the user to retract theneedle, after use, into the wings. Thusreducing the probability of accidentalneedle sticks.Hospital policy will determine thelength of time that this device, orcurrently marketed devices, may beused prior to changing. The similarityof the materials used in this device tocurrently marketed devices will allowthe healthcare worker to maintain thesame procedure which they arecurrently following. Neither thisdevice, nor the currently marketeddevices for the same intended usemake any claims or recommendationsfor length of administration prior toset change. | intended for temporarycannulation (non-implantable, less than 30days) to vascular accessfor extracorporeal bloodtreatment. The device isintended for single useonly and has an anti-stickfeature integrated as partof the Needle Set whichaids in prevention ofneedle-stick injuries. | |
|---|---|---|---|
| Material | Refer to section 15.Most of the materialused in this device isfrom K895481 andK110157 | Refer to K895481 | Refer to K110157 |
807.92(b) SAFETY AND EFFICACY
Biocompatibility
| Biocompatibility Testing | ||
|---|---|---|
| Test | Test Method | Results |
| Cytotoxicity | ISO 10993-5 | Pass |
| Sensitization | ISO 10993-10 | Pass |
| Irritation Or IntracutaneousReactivity | ISO 10993-10 | Pass |
| Systemic Toxicity (Acute) | ISO 10993-11 | Pass |
| Subchronic Toxicity | ISO 10993-6 | Pass |
| (Subacute Toxicity) | ISO 10993-11 | |
| Genotoxicity | ISO 10993-3 | Pass |
| Implantation | ISO 10993-6 | Pass |
| Hemocompatibility | ISO 10993-4 | Pass |
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Sterilization
Sterilization conditions have been validated according to ANSI/AAMI/ISO 11135, Sterilization of Health Care Products – Part 1; Requirements for development validation and routine control of sterilization process for medical devices to provide a Sterility Assurance Level (SAL) of 10°.
Residual ethylene oxide (EO) and ethylene chlorohydrin (ECH) residuals will meet requirements for limited exposure devices (contact up to 24 hours) prior to use, based on ANSI/AAMI/ISO 10993-7, Biological Evaluation of medical device – Part 7; Ethylene Oxide Sterilization residuals. Residual EO will not exceed 4 mg per device and residual ECH will not exceed 9 mg per device.
PERFORMANCE
Conformance to ISO 10555-1
The JMS SWC successfully passed the following performance tests, demonstrating conformance with ISO-10555-1:
| ISO 10555-1 Compliance Testing of the JMS Safe Wing Cath (SWC) | ||
|---|---|---|
| Test | Test methods | Results |
| Surface inspection | ISO 10555-1 | Passed |
| Corrosion resistance | ISO 10555-1 | Passed |
| Force at break (catheter and hub, tubing and female connector, tubing to needle hub | ISO 10555-1 | Passed |
| Freedom for leakage (Positive pressure) | ISO 10555-1 & JIS T3223:2011 | Passed |
| Test Method of Air Leakage into Hub Assembly during Aspiration (Negative Pressure) | ISO 10555-1 | Passed |
| Flow rate | ISO 10555-1 | Passed |
| Catheter under X-Ray | ISO 10555-1 | Passed |
| Determination of Strength of Union Hub and Needle tube | ISO 10555-1 | Passed |
| Leakage Needle hub/Tubing/Female Connector | ISO 10555-1 & JIS T3223:2011 | Passed |
| Additional Tests | ||
| Catheter under X-Ray | Passed |
2. Simulated Use and Device Performance
A Simulated Clinical Use Test for the JMS Safe Wing Cath was conducted comprising 43 healthcare workers from the Washington /Baltimore area to evaluate product performance and
{5}------------------------------------------------
usability. Performance Testing on over 500 samples was 100% success with no device failures and all devices performing as intended.
3. Comparison to predicate
The following in-house bench testing was conducted to demonstrate equivalent performance with the predicate device.
| Test | Result |
|---|---|
| Catheter (Elastic Modulus in Tension, Tensile Strength, and Tensile Elongation) | No significant difference |
| Catheter Flexural Modulus (Three Point Bend) | No significant difference |
| Force Break of Tubing and Female Connector | No significant difference |
| Force Break of tubing to needle hub | No significant difference |
| Force Break needle and needle hub | No significant difference |
| Determine maximum positive pressure for Nexvia & SWC . | Pressure determined |
| Catheter collapse Pressure test | No significant difference |
| Priming volume determination | Volumes determined |
CONCLUSION
807.92(b)(3)
The JMS SWC is a modification of predicate 2 into a catheter equivalent that of predicate 1. The JMS SWC has similar appearance and safety anti needle stick feature as predicate 2. As a catheter, the JMS SWC has fewer applications than that of predicate 1, but for the intended applications, it has equivalence in intended use and mechanical / performance specifications. The appearance of JMS SWC is different from predicate 1 device, but they are both closed I.V. catheter systems. All specifications addressed have been analyzed, verified and validated with supporting data enclosed in this 510(k) document and there are no issue on the safety and effectiveness of the device performance if used as intended.
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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the emblem. The text is in uppercase letters and is positioned to encircle the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5. 2013
JMS North America Corporation C/O Ms. Yolanda Smith Regulatory Consultant Smith Associates 1468 Harwell Avenue CROFTON MD 21114
Re: K121488
Trade/Device Name: JMS Safe Wing Cath (SWC) Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: February 19, 2013 Received: February 25, 2013
Dear Ms. Smith:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 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 - Ms. Smith
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 Actor 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 (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 go to http://www.fda.goy/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
Image /page/7/Picture/6 description: The image contains a stylized signature or logo. It features the word "for" at the top left, followed by a looping design that connects to the name "Nich Urowitz". To the right of the name, there is a triangular shape with parallel lines inside, resembling a stylized letter "A". The overall design is intricate and appears to be hand-drawn.
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): _ 12 | 488
Device Name: JMS Safe Wing Cath (SWC)
Indications for Use:
JMS Safe Wing Cath (SWC) is intended for short-term (less than 30 days) access to patient's vascular system for intravascular fluid administration and to sample blood, and to monitor blood pressure. The device is intended for single use only and has an anti-stick feature integrated which aids in prevention of needle-stick injuries.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/8/Picture/10 description: The image shows the name "Alan M. Stevens" in a large font on the left side. On the right side, the word "Date:" is written above the date "2013.03.04", the time "14:01:29", and the timezone "-05'00". The date, time, and timezone are enclosed in a geometric shape.
as Sinn eslology, General Hospital
$10(k) Number
Page __ of
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).