(226 days)
A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.
A needle and hub device for the percutaneous introduction of a guide wire, with a hub modification to allow one-handed activation of a sheath to cover the needle and help prevent accidental needle sticks during use and disposal.
The provided document is a 510(k) Premarket Notification for the "SafetyNET Guidewire Introducer". It contains administrative information, an intended use statement, and a declaration of compliance with ISO 10993-1. However, it does not include specific acceptance criteria, performance data, or details of studies typically found in a clinical or performance study report.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be provided:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "Product and materials meet all applicable test requirement per ISO 10993-1" under the "Testing" section, which refers to biocompatibility testing. It implies that these requirements were met, but it does not specify what those "applicable test requirements" or their acceptance criteria were, nor does it provide the results of those tests or any other performance metrics for the device itself (e.g., success rate of guidewire introduction, effectiveness of the safety shield in preventing needle sticks, etc.).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document does not describe any specific performance or clinical studies, and therefore no information on sample sizes or data provenance for a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. There is no mention of a test set requiring ground truth establishment by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. There is no mention of a test set or any adjudication process.
5. 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
- Cannot be provided. This device is a manual surgical instrument (a guidewire introducer with a safety mechanism), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a manual surgical instrument, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. There is no mention of any ground truth being established as no such study is described.
8. The sample size for the training set
- Cannot be provided. There is no mention of a training set, as the device is not an AI/ML algorithm.
9. How the ground truth for the training set was established
- Cannot be provided. There is no mention of a training set or ground truth establishment.
Summary of available information related to testing:
The document briefly mentions "Testing" and states:
- "Product and materials meet all applicable test requirement per ISO 10993-1"
- ISO 10993-1 refers to "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." This standard guides the evaluation of biocompatibility but does not define specific performance criteria for the function of a device. It indicates that the materials used in the SafetyNET Guidewire Introducer have been assessed for their biological safety in accordance with this standard. No specific data or acceptance criteria for this testing are provided in this document.
For this type of device (a manual surgical instrument), the "study" demonstrating its safety and effectiveness for a 510(k) submission typically relies on substantial equivalence to existing predicate devices and in vitro/bench testing (like biocompatibility, sterility, strength, dimensions, and the function of the safety mechanism) rather than large clinical trials or AI performance evaluations. The document does not elaborate on these specific tests or their results, instead summarizing them with the ISO 10993-1 compliance statement.
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p. (of)
Premarket Notification
SafetyNET Guidewire Introducer
InjectiMed Inc
Ventura, CA
VIII. Premarket Notification 510(k) Summary
| Submitted by: | InjectiMed Inc2737 Palma DriveVentura, CA 93003 | AUG - 8 2008 |
|---|---|---|
| Contact person: | Thomas C. KuracinaPresident | |
| Date prepared: | December 20, 2007 | |
| Device proprietary name: | SafetyNET Guidewire Introducer | |
| Common name: | Percutaneous Guidewire Introducer | |
| Classification name: | Manual surgical instrument for general use21 CFR Sec. 878.4800 | |
| Predicate devices: | SafetyNET Guidewire Introducer (K040029) | |
| Light Saber Introducer Needle (K013040) | ||
| Description of the device: | A needle and hub device for the percutaneousintroduction of a guide wire, with a hub modificationto allow one-handed activation of a sheath to coverthe needle and help prevent accidental needle sticksduring use and disposal. | |
| Intended use: | A percutaneous guidewire introducer for vascularand non-vascular procedures with activating safetyshield to reduce needle stick injury during use anddisposal. | |
| Characteristics: | Sterile, single-use, disposable stainless steel needlewith modified polycarbonate hub/spring assembly | |
| Testing | Product and materials meet all applicable testrequirement per ISO 10993-1 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
InjectiMed, Inc. % Washington Regulatory Consultants Mr. Richard Hunter, MS, RAC 5616 Mariola Place, NE Albuquerque, New Mexico 87111
AUG - 8 2008
Re: K073664
Trade/Device Name: SafetyNET Guidewire Introducer Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: II Product Code: MDM Dated: July 7, 2008 Received: July 10, 2008
Dear Mr. Hunter:
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 (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.
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.
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Page 2 Mr. Richard Hunter, MS, RAC
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (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 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/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Milliman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification SafetyNET Guidewire Introducer
InjectiMed Inc Ventura, CA
V. Indications for Use Statement
510(k) Number:
To be assigned
Device Name:
SafetyNET Guidewire Introducer
Indications for Use:
A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart )
(PLEASE DO NOT WRITE BELOW THIS LINE-
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 16073664
§ 878.4800 Manual surgical instrument for general use.
(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.