(113 days)
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
The PICC WAND® Peelable Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and a Peelable Sheath Introducer in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
The provided document describes the 510(k) premarket notification for the PICC WAND® Peelable Safety Introducer. The information primarily focuses on establishing substantial equivalence to a predicate device through biocompatibility and performance testing. There is no information regarding AI-based devices or studies that would involve AI models. Therefore, many of the requested categories are not applicable to this submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
| Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | "Biocompatibility testing... has been completed to demonstrate the biological safety... Test results indicate that the device is equivalent to the predicate device." |
| Biomechanical Performance/Mechanical Requirements | "in vitro bench testing has been completed to demonstrate the... biomechanical performance characteristics... Test results indicate that the device is equivalent to the predicate device and satisfies mechanical performance requirements for its intended use." |
| Sterility | "Provided 'STERILE' by ethylene oxide gas to a sterility assurance level of 10-6." |
| Substantial Equivalence (Overall Conclusion) | "The results of testing demonstrate that the PICC WAND® Peelable Safety Introducer is substantially equivalent to the predicate device in design, function, and indications for use." |
Study Details (Focus on Safety and Performance, Not AI)
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Sample size used for the test set and the data provenance:
The document does not specify the sample sizes for the biocompatibility or in vitro bench testing. The data provenance is not explicitly mentioned (e.g., country of origin), but it is implied to be from studies conducted by Access Scientific, Inc. for regulatory submission in the USA. These tests are prospective. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The studies described are laboratory/bench tests and biocompatibility assessments, not clinical studies requiring expert ground truth for interpretation of medical images or data. -
Adjudication method for the test set:
This information is not applicable as the studies are not clinical trials that would require adjudication for outcomes. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device (catheter introducer), not an AI-powered diagnostic or assistive tool. No MRMC study was performed. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm or AI. -
The type of ground truth used:
For biocompatibility, the ground truth would be established by validated test methods adhering to ISO standards (e.g., ISO 10993 series) for biological safety, with results compared against predetermined safety thresholds. For biomechanical performance, the ground truth would be established by engineering specifications and performance requirements derived from the predicate device and intended use, measured through in vitro bench testing. -
The sample size for the training set:
Not applicable. This device does not involve a training set as it is not an AI/ML product. -
How the ground truth for the training set was established:
Not applicable (no training set).
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KC93022
510(K) SUMMARY
JAN 20 2010
11.1 SUBMITTER INFORMATION
| A. | Company Name: | Access Scientific, Inc. |
|---|---|---|
| B. | Company Address: | 12526 High Bluff Drive, Suite 360San Diego, CA 92130 |
| C. | Company Phone: | (858) 259-8333 |
| D. | Company Facsimile: | (858) 259-5298 |
| E. | Contact Person: | Albert MisajonVice President, Regulatory Affairs andQuality Assuranceamisajon@the-wand.com |
DEVICE IDENTIFICATION 11.2
| A. | Device Trade Name: | the PICC WAND® Peelable Safety Introducer |
|---|---|---|
| B. | Common Name: | Catheter Introducer |
| C. | Classification Name(s): | Introducer, Catheter |
| D. | Classification Regulation(s): | 21 CFR 870.1340 |
| E. | Device Class: | Class II |
| F. | Product Code: | DYB |
| G. | Advisory Panel: | Cardiovascular |
11.3 IDENTIFICATION OF PREDICATE DEVICE
The PICC WAND® Peelable Safety Introducer is substantially equivalent to the WAND® MicroAccess Safety Introducer manufactured by Access Scientific, Inc. and cleared for commercial distribution under 510(k) K090372.
11.4 DEVICE DESCRIPTION
The PICC WAND® Peelable Safety Introducer is an integrated sterile, single-use intravascular catheter introducer. It is designed to incorporate a combination of devices into an all-in-one device that provides the clinician with a safe and simple approach to the Modified Seldinger technique, and thereby accelerate the procedure required to place indwelling intravascular catheters. The device includes an Introducer Needle, Guidewire, Dilator, and a Peelable Sheath Introducer in a single integrated device, and incorporates a safety mechanism to guard against accidental needlestick.
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11.5 INDICATIONS FOR USE
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
11.6 BIOCOMPATIBILITY AND PERFORMANCE TESTING
A program of design verification testing including biocompatibility testing and in vitro bench testing has been completed to demonstrate the biological safety and biomechanical performance characteristics of the PICC WAND® Peelable Safety Introducer. Test results indicate that the device is equivalent to the predicate device and satisfies mechanical performance requirements for its intended use.
11.7 STERILITY
The PICC WAND® Peelable Safety Introducer is provided 'STERILE' by ethylene oxide gas to a sterility assurance level of 10-9.
11.8 CONCLUSIONS DRAWN FROM STUDIES
The results of testing demonstrate that the PICC WAND® Peelable Safety Introducer is substantially equivalent to the predicate device in design, function, and indications for use.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring; MD 20993-0002
JAN 2 0 2010
Access Scientific, Inc c/o Mr. Albert Misajon Vice President, Regulatory Affairs and Quality Assurance 12526 High Bluff Drive, Ste 360 San Diego, CA 92130
Re: K093022
Trade Name: PICC WAND Peelable Safety Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: December 15, 2009 Received: December 16, 2009
Dear Mr. Misajon:
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. Drue, 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 - Mr. Albert Misajon
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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 yours,
en R. balmer
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K093022
Device Name:
the PICC WAND® Peelable Safety Introducer
Indications for Use:
The PICC WAND® Peelable Safety Introducer is used to facilitate the placing of an intravascular catheter through the skin into the circulatory system.
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)
Dummer R. Salunes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K 69 30 22
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).