(302 days)
Not Found
No
The summary describes a simple mechanical needle set and makes no mention of AI or ML.
No.
The device is described as an "access device" and a "needle set" for dialysis and pheresis procedures, which are medical treatments, but the device itself is for access and insertion, not the therapeutic delivery or direct treatment of a condition. Its function is to facilitate the connection for the therapy, not to provide the therapy itself.
No
The device description indicates it is an "access device for dialysis and pheresis procedures," focusing on needle insertion and cannulation, not on diagnosing medical conditions.
No
The device description clearly states it consists of physical components like a needle/cannula, flexible tube, and locking connector, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for accessing the body for dialysis and pheresis procedures. This is a direct interaction with the patient's body for treatment/procedure, not for testing samples in vitro (outside the body).
- Device Description: The description details a needle set for physical access, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which is the core function of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Medisystems Buttonhole Needle Sets are indicated for use as an access device to percutaneously inject fluids into, or withdraw fluids from, the body using a constant site or "buttonhole" method of needle insertion.
Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site or "buttonhole" method of needle insertion.
Product codes
78 FIE
Device Description
The Medisystems Buttonhole Needle Set consists of a hollow, rigid needle/cannula, a flexible tube, and locking connector to provide access through the skin at a constant or "buttonhole" site. Different degrees of point sharpness are offered to accommodate creation of the buttonhole site and cannulation through an established buttonhole site.
The technical characteristics of the Medisystems Buttonhole Set consist of a rigid needle cannula mounted on a hub with wings or finger grips to allow insertion through the skin. The needle hub is bonded to a flexible tube and locking connectors that allow attachment to other compatible medical devices.
Different degrees of needle sharpness are offered. The sharp version of the Medisystems Buttonhole Needle Set is used to allow the initial creation of a scar tunnel or buttonhole. The duller versions are used for repeated access through the buttonhole site. The duller point and cutting surfaces of the needle/cannula minimize cuts in the adjacent tissue, enlargement of the hole, and bleeding along the needle's path.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
To assure that the device is safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to; sterility, pyrogenicity, physical testing, and visual examination of both in-process and finished product.
The required testing is defined by written and approved procedures that conform to the product design specifications. This testing for the Medisystems Buttonhole Needle Sets is defined in detail in the "Device Master Records."
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
JAN - 6 2000
Image /page/0/Picture/1 description: The image shows the number K990803 at the top. Below that, the text "Page 1 of 2" is written in cursive. The text is slightly blurry, but still legible. The image is black and white.
Section I
510(k) Summary 21 CFR §807.92
I. Submitter:
| A. Name: | McKenna & Cuneo, L.L.P.
on behalf of Medisystems Corporation |
|-------------|-----------------------------------------------------------------|
| B. Address: | 1900 K Street, NW
Washington, DC 20006 |
C. Phone and Fax Numbers: Phone: 202-496-7500 Fax: 202-496-7756
D. Contact Person: Mr. Larry R. Pilot
II. Date of preparation of this Summary: February 25, 1999
III. Trade Name: Medisystems Buttonhole Needle Sets
IV. Common Name: Access Device
V. Classification Name: Single Lumen Hypodermic Needle
VI. The Marketed Device(s) to which Equivalence is Claimed: The Medisystems Buttonhole Needle Sets that are the subject of this submission are substantially equivalent to Needle Sets described by Medisystems' 510(k) number K823068 for Medisystems Arterial Venous Fistula Needles in terms of their design and materials of construction and Becton-Dickinson's 510(k) number K951254 for Hypodermic Needles in terms of their indications for use.
VII. Product Description: The Medisystems Buttonhole Needle Set consists of a hollow, rigid needle/cannula, a flexible tube, and locking connector to provide access through the skin at a constant or "buttonhole" site. Different degrees of point sharpness are offered to accommodate creation of the buttonhole site and cannulation through an established buttonhole site.
VIII. Statement of Intended Use Compared to Predicate Device: The indications for use of the Arterial Venous Fistula Needles predicate device are to allow access during dialysis procedures. Medisystems Buttonhole Needle Sets are indicated for use as an access device to percutaneously inject fluids into, or withdraw fluids from, the body using a constant site or "buttonhole" method of needle insertion. This is identical to the indications for use of the hypodermic needle predicate
1
device except for the constant site of use for the Medisystems Buttonhole Needle Sets. Both predicate devices are used typically at a different site for each cannulation or puncture.
IX. Discussion of Technological Characteristics: The technical characteristics of the Medisystems Buttonhole Set consist of a rigid needle cannula mounted on a hub with wings or finger grips to allow insertion through the skin. The needle hub is bonded to a flexible tube and locking connectors that allow attachment to other compatible medical devices.
Different degrees of needle sharpness are offered. The sharp version of the Medisystems Buttonhole Needle Set is used to allow the initial creation of a scar tunnel or buttonhole. The duller versions are used for repeated access through the buttonhole site. The duller point and cutting surfaces of the needle/cannula minimize cuts in the adjacent tissue, enlargement of the hole, and bleeding along the needle's path.
X. Safety and Effectiveness: To assure that the device is safe and effective, all finished products are tested and must meet all required release specifications before distribution. The testing required for release includes, but is not limited to; sterility, pyrogenicity, physical testing, and visual examination of both in-process and finished product.
The required testing is defined by written and approved procedures that conform to the product design specifications. This testing for the Medisystems Buttonhole Needle Sets is defined in detail in the "Device Master Records."
2
Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an abstract image of an eagle.
JAN - 6 2000
Medisystems Corporation c/o Mr. Larry R. Pilot McKenna & Cuneo, L.L.P. 1900 K Street, N.W. Washington, D.C. 20006-1108 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K990803 Medisystems Buttonhole Needle Sets Dated: November 1, 1999 Received: November 1, 1999 Regulatory Class: Il 21 CFR §876.5540/Procode: 78 FIE
Dear Mr. Pilot:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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.
If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal. Ear. Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Section A
510(k) Number (if known): __ K990803
Device Name: Buttonhole Needle Sets
Indications For Use:
Medisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site or "buttonhole" method of needle insertion.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Prescription Use
OR
Over-The-Counter Use __
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number.
Concurrence of CDRH, Office of Device Evaluation (ODE)