A.V. FISTULA BLUNT NEEDLE SET

K082882 · Jms North America Corp. · FIE · Jan 21, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K082882
• Device Name: A.V. FISTULA BLUNT NEEDLE SET
• Applicant: Jms North America Corp.
• Product Code: FIE · Gastroenterology, Urology
• Decision Date: Jan 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5540
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The JMS Blunt AV Fistula Needle Set is intended for temporary cannulation (nonımplantable, less than 30 days) to vascular access for extracorporeal blood treatment The device is intended for single use only The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites

Device Story

JMS AV Fistula Blunt Needle Set is a non-implanted blood access device; consists of a blunt needle attached to wings, flexible tubing, and a luer lock connector. Used for temporary cannulation of developed 'constant site' vascular access for extracorporeal blood treatment. Single-use device. Operates as a physical conduit for blood flow during extracorporeal procedures. Benefits patient by providing vascular access for treatment while minimizing trauma to established access sites due to blunt needle design.

Clinical Evidence

No clinical data. Bench testing was conducted to verify performance and safety.

Technological Characteristics

Non-implanted blood access device; includes needle, wings, flexible tubing, and luer lock connector. Materials used in blood-contact components are identical to predicate devices. Single-use, non-implantable.

Indications for Use

Indicated for temporary cannulation (less than 30 days) of developed 'constant site' vascular access for extracorporeal blood treatment in patients requiring such access.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Medisystems Buttonhole Needle Sets (K990803)
• JMS AV Fistula Needle Set WingEater (K010406)
• JMS Sysloc Mini AVF and Apheresis Needle Set (K070234)

Submission Summary (Full Text)

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K082882

1 of 2

## 510(K) SUMMARY

This summary of 5l0(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807 92

The assigned 510(k) number is __

# 1. Manufacturer and Sponsor Contact Information

1 1 Manufacturer JMS Singapore Pte Ltd 440 Ang Mo Kıo Industrial Park 1 Singapore 569620

JAN 2 1 2009

1 2 Sponsor JMS North America Corporation 22320 Foothill Blvd , Suite 350 Havward, CA 94541 USA

1 3 Contact Information Yvonne Lım QA Specialist JMS North America Corporation 22320 Foothill Blvd, Suite 350 Hayward, CA 94541 Telephone [phone] Fax [phone]

Date Summary Prepared September 29, 2008

- JMS AV Fistula Blunt Needle Set 2 Name of the Device· 21 CFR 876 5540 Classification name: FIE Product Code
### 3. Common or Usual Name

AV Fistula Blunt Needle Set

#### Predicate Device Information: 4.

The predicate device used in this submission is

- 1) Medisystems Buttonhole Needle Sets (K990803),
- 2) JMS AV Fistula Needle Set WingEater (K010406)
- 3) JMS Sysloc Mini AVF and Apheresis Needle Set (K070234)

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K08 2882
2%2

## 5 Device Description.

JMS AV Fistula Blunt Needle Set is intended as a non-implanted blood access device, which consists of a needle that is attached to wings, a flexible tube and a luer lock connector

# 6. Intended Use.

The JMS Blunt AV Fistula Needle Set is intended for temporary cannulation (nonımplantable, less than 30 days) to vascular access for extracorporeal blood treatment The device is intended for single use only The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites

### Comparison to Predicate Devices 7.

The predicate device used in this submission is Medisystems Buttonhole Needle Sets (K990803) in terms of indications of use and performance characteristics In terms of material, the predicate device is JMS AV Fistula Needle Set WingEater (K010406) and JMS Sysloc Mini AVF and Apheresis Needle Set (K070234)

### Dıscussion of Non-Clinical Tests Performed for Determination of 8. Substantial Equivalence and Discussion of Clinical Tests Performed are as follows.

Functional tests performance data are comparable to predicate device JMS A V Fistula Blunt Needle Set has the same intended usage, same materials used in the blood-contact components, and adopts identical fundamental scientific technology as the predicate devices Bench testing was conducted to verify that the JMS AV Fistula Blunt Needle Set performs as intended to be a safe and effective medical device, data and reports are enclosed within this submission document

### 9 Conclusions

The information provided in this submission clearly demonstrates the substantial equivalence of JMS AV Fistula Blunt Needle Set to the predicate device Medisystems Buttonhole Needle Sets (K990803) and JMS AV Fistula Needle Set WingEater (K010406) and JMS Sysloc Mini AVF and Apheresis Needle Set (K070234)

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized bird-like symbol in the center. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES USA' and is arranged along the upper and lower curves of the circle. The central symbol consists of three curved lines that resemble a bird in flight, with the lines becoming more wavy towards the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 21 2009

JMS North America Corporation c/o Ms Maria Griffin Official Correspondent MDI Consultants, Inc 55 Northern Blvd , Suite 200 GREAT NECK NY 11021

Re K082882

> Trade/Device Name JMS A V Fistula Blunt Needle Set Regulation Number 21 CFR \$876 5540 Regulation Name Blood access device and accessories Regulatory Class II Product Code FIE Dated December 30, 2008 Received December 31, 2008

Dear Ms Griffin

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 pror 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, Insting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteratıon

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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 (OS) 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 os 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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter

| 21 CFR 876 xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884 xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807 97) For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474 For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464 You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http //www fda gov/cdrh/industry suppot/index html

Sincerely yours,

Laura B. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K082882

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Indications for Use

Page -1 of 1

510(k) Number (if known)

Device Name JMS A V Fistula Blunt Needle Set

Indıcatıons For Use

The JMS Blunt AV Fistula Needle Set is intended for temporary cannulation (nonımplantable, less than 30 days) to vascular access for extracorporeal blood treatment The device is intended for single use only The JMS AV Fistula Blunt Needle Set is for use on developed 'constant site' access sites

Prescription Use X (Per 21 CFR 801 Subpart D)

OR

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdomina
Radiological Devices
510(k) Number K082882