(136 days)
Not Found
No
The description focuses on the mechanical function of a rigid plastic device for securing a needle and immobilizing a vein. There is no mention of software, algorithms, data processing, or any terms related to AI/ML.
No
The device is a securement device for fistula needles during hemodialysis, designed to prevent needle dislodgement and immobilize the vein, rather than directly treating a medical condition itself.
No
Explanation: The device is described as a securement device for a fistula needle during hemodialysis and cannulation, designed to prevent dislodgement and immobilize the vein. Its function is purely mechanical support and stabilization, not to diagnose any medical condition or disease.
No
The device description clearly states it is a "removable, rigid plastic securement device," indicating it is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "secure the fistula needle to the patient's skin." This is a physical securement function, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "removable, rigid plastic securement device" that attaches to a needle set. Its function is to provide physical support and stability.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Anatomical Site: The device interacts with the patient's skin and vein/access, which are external or directly related to the physical access point, not internal biological processes being measured.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely mechanical securement.
N/A
Intended Use / Indications for Use
The Medisystems Hemodialysis Fistula Needle Securement Device, SiteGuard, is intended for use to secure the fistula needle to the patient's skin.
The SiteGuard needle securement device has the following features:
- a. It allows the needle to be held at a consistent angle during treatment;
- b. It secures wing/hub to the patient's skin and helps prevent movement and/or dislodgement of the needle during use; and,
- c. It helps to immobilize the patient's vein or access during cannulation so that it is not necessary for caregivers to hold the vein or access with their fingers.
Product codes
KMK, FIE
Device Description
The subject of this 510(k) is a removable, rigid plastic securement device that is attached to the AVF needle set by the care giver. The SiteGuard securement device will be included in the unit packaging pouch with the Medisystems AVF needle set and also will be available for purchase as an individually packaged accessory.
Because the tape, the AVF wing, and the patient's skin are flexible, the needle may dislodge or move within the patient's access during treatment due to this inherent flexibility. The securement device adds a rigid structure to increase the ability of the tape to prevent the needle from accidentally dislodging or moving within the patient's vascular access.
This accessory also will immobilize the patient's vein during insertion of the cannula so that it is not necessary for caregivers to hold the vein or access with their fingers. The channel along the bottom of the securement device is designed to immobilize the patient's vein during insertion. This feature is especially helpful for patients who have newly created fistulas or implanted grafts because new accesses tend to move during cannulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin, patient's vein or access
Indicated Patient Age Range
Not Found
Intended User / Care Setting
care giver
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
To assure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution.
The required testing is defined by written and approved procedures that conform to the product design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Page 1 of 3
510(k) Summary of Safety and Effectiveness FEB 1 2 201 K062953
This 510(k) summary of safety and effectiveness information is submitted as part of the PreMarket Notification in accordance with the requirements of 21 CFR Part 807, Subpart E and Section 807.92.
1. Identification of Submitter:
| Submitter: | Medisystems Corporation |
|---|---|
| Address: | 701 Pike Street 16th Floor |
| Seattle, WA 98101-3016 | |
| Phone: | 206-834-1238 |
| Fax: | 206-834-1201 |
Contact Person:
Ms. Laura Plath Manager, Product Surveillance
Date Prepared:
January 26, 2007
2. Identification of Product:
Trade name:
Regulatory Number: Regulation Name: Common name: Regulatory Class: Product Code: Classification panel: Manufacturer:
Medisystems Hemodialysis Fistula Needle Securement Device: SiteGuard 21 CFR §880.5210 Device, Intravascular Catheter Securement Fistula Needle Securement Device Class II KMK General Hospital Medisystems Corporation 701 Pike Street 16th Floor Seattle, WA 98101-3016
1
3. Indications for Use
The Medisystems Hemodialysis Fistula Needle Securement Device, SiteGuard, is intended for use to secure the fistula needle to the patient's skin.
KO62953
The SiteGuard needle securement device has the following features:
- a. It allows the needle to be held at a consistent angle during treatment;
- b. It secures wing/hub to the patient's skin and helps prevent movement and/or dislodgement of the needle during use; and,
- c. It helps to immobilize the patient's vein or access during cannulation so that it is not necessary for caregivers to hold the vein or access with their fingers.
4. Device Description
The subject of this 510(k) is a removable, rigid plastic securement device that is attached to the AVF needle set by the care giver. The SiteGuard securement device will be included in the unit packaging pouch with the Medisystems AVF needle set and also will be available for purchase as an individually packaged accessory.
Because the tape, the AVF wing, and the patient's skin are flexible, the needle may dislodge or move within the patient's access during treatment due to this inherent flexibility. The securement device adds a rigid structure to increase the ability of the tape to prevent the needle from accidentally dislodining or moving within the patient's vascular access.
This accessory also will immobilize the patient's vein during insertion of the cannula so that it is not necessary for caregivers to hold the vein or access with their fingers. The channel along the bottom of the securement device is designed to immobilize the patient's vein during insertion. This feature is especially helpful for patients who have newly created fistulas or implanted grafts because new accesses tend to move during cannulation.
2
5. Comparison with Legally Marketed Devices
The marketed devices which are substantially equivalent to the SiteGuard securement device are as follows:
- TNT Moborg Intl., LTD, Immobile Non-sterile and Immobile A/C t non-sterile (K941850); and.
- TNT Immobile sterile and Immobile A/C sterile (K941940). This . 510(k) has been supplemented with the Immobile FST product, which is designed to provide fistula access needle control.
- The term "substantially equivalent" as used in this premarket notification is intended to be a determination of substantial equivalence from an FDA/regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable and does not diminish any patent claims related to this product or to the technology used to manufacture the product.
6. Safety and effectiveness
To assure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution.
The required testing is defined by written and approved procedures that conform to the product design specifications.
7. Conclusions
The SiteGuard Fistula Needle Securement Device, is substantially equivalent to the identified legally marketed devices. Both manufacturers' products are provided sterile and non-sterile. Both manufacturers' products are used during cannulation for fistula needle access control and for subsequent securement of the vascular access devices. The potential hazards have been studied and controlled as part of the product development process, including risk analysis, test and design considerations, and verification and validation testing processes. There are no new issues of safety or effectiveness resulting from the inclusion of this accessory in the legally marketed needle set.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Laura Plath Manager, Product Surveillance Medisystems Corporation 701 Pike Street, 16th Floor SEATTLE WA 98101-3016
FFB 1 2 2007
Re: K062953
Trade/Device Name: Medisystems Hemodialysis Fistula Needle Securement Device: SiteGuard Regulation Number: 21 CFR §876.5540 Regulation Name: Blood access device and accessories Regulatory Class: II Product Code: FIE Dated: January 30, 2007 Received: January 31, 2007
Dear Ms. Plath:
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.
If your 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/3/Picture/10 description: The image is a black and white circular logo or emblem. The central element is the acronym "FDA" in a bold, blocky font, with the word "Centennial" written in a cursive style font underneath. Above the acronym, the years "1906 - 2006" are displayed. Three stars are arranged in a horizontal line below the word "Centennial". The entire design is encircled by text that follows the curve of the circle, creating a border around the central elements.
Protecting and Promoting Public Health
4
Page 2 -
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 (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.
This letter will allow you to begin marketing your device as described in your Section 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), 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) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K0629553
Statement of Indications for Use
510(k) Number:
Device Name:
Medisystems Hemodialysis Fistula Needle Securement Device: SiteGuard
Indications for Use:
The Medisystems Hemodialysis Fistula Needle Securement Device, SiteGuard, is intended for use to secure the fistula needle to the patient's skin.
The SiteGuard needle securement device has the following features:
- a. It allows the needle to be held at a consistent angle during treatment;
- b. It secures wing/hub to the patient's skin and helps prevent movement and/or dislodgement of the needle during use; and,
- c. It helps to immobilize the patient's vein or access during cannulation so that it is not necessary for caregivers to hold the vein or access with their fingers.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Broadon
(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devic 510(k) Number.