(86 days)
The Navigator (stylet) is a stainless steel wire rod, inserted into the catheter to assist with insertion and placement of the catheter in the peritoneum.
Stainless steel wire rod intended to aid in the manipulation of or insertion of the catheter for placement in the peritoneum.
The provided document is a 510(k) summary for a medical device called "Navigator (stylet)". This document describes the device, its intended use, and biocompatibility testing. It is a premarket notification for a medical device and therefore does not contain information related to software algorithm performance, such as acceptance criteria for diagnostic accuracy, sample sizes for test sets in an AI context, or ground truth establishment by experts.
This document describes a physical medical device (a stainless steel wire rod or stylet), not a software algorithm or an AI-powered diagnostic tool. The "acceptance criteria" discussed are related to the physical properties and biological compatibility of the device, not its performance in a diagnostic or analytical capacity. Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to the content provided.
Here's an attempt to answer the relevant questions based on the provided text, and to explicitly state when information is not applicable or available:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Cytotoxicity Study | Non-cytotoxic | Pass |
| Hemolysis Study | Non-hemolytic | Non-Hemolytic |
| Dimensional Equivalence | Equivalent to Quinton's stylet | Dimensionally equivalent |
| Material Equivalence | Stainless steel | Manufactured from stainless steel |
| Sterilization | Sold sterile | Sold double pouched and sterile |
Note: The acceptance criteria for "Pass" in the cytotoxicity study and "Non-Hemolytic" in the hemolysis study are directly stated or directly implied by the result.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The document describes a physical device, not an algorithm tested with a data set of images or patient data. Biocompatibility studies are typically performed on samples of the device material, not a "test set" in the context of an algorithm.
- Data Provenance: Not applicable.
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)
- Not applicable. Ground truth as typically defined for algorithms (e.g., disease presence/absence based on expert consensus) is not relevant for the assessment of a physical stylet's biocompatibility or dimensional equivalence. The "ground truth" for biocompatibility is established by standardized laboratory tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretation of diagnostic data for algorithm training/testing, which is not relevant here.
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
- Not applicable. This device is a physical stylet, not an AI-powered diagnostic tool. MRMC studies evaluate the impact of AI on human reader performance, which is not relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not a standalone software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of an algorithm's diagnostic performance. For biocompatibility, the "ground truth" is provided by the results of standardized biological assays (cytotoxicity and hemolysis tests) and physical/material comparisons against predicate devices.
8. The sample size for the training set
- Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set or ground truth establishment in the context of an algorithm.
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1972521
OCT - 1 1997
510 (k) Summary
| Company: | Sil-Med Corporation700 Warner BoulevardTaunton, MA 02780 |
|---|---|
| Telephone:Fax: | (508) 823-7701(508) 823-1438 |
| Contact Person: | Karen K. SylviaQA/QC Manager |
| Trade Name: | Navigator |
| Common Name: | Stylet |
| Classification Name: | Introduction/drainage catheter and accessories accessory intendedto aid in the manipulation of or insertion of the device into the body.(878.4200) |
| Description: | Stainless steel wire rod intended to aid in the manipulation of orinsertion of the catheter for placement in the peritoneum. |
| Predicate Device: | Accurate Surgical's Insertion StyletMedigroup's Catheter StylettesQuinton's Stylet |
| Intended Use: | The Navigator (stylet) is a stainless steel wire rod, inserted into thecatheter to assist with insertion and placement of the catheter in theperitoneum. |
Biocompatability Testing:
| Test | Results |
|---|---|
| Cytotoxicity Study | Passwas were and the many of production of the maint the first of the comments in the first and the line |
| . But the bit has and the large of the count of the comments of the commended inHemolysis Study - In Vitro | Non-HemolyticCall and Concession of Children a Le Life Commend College of Children Comments of Children Comments of Children Comments of Children Comments of Children |
Sil-Med Corporation's Navigator (stylet) is dimensionally equivalent to Quinton's stylet and equivalent to offerings by Accurate Surgical and Medigroup. The intended use of all stylets are the same. The Navigator is manufactured from stainless steel as are the predicate stylets. The Navigator will be sold double pouched and sterile.
SIL-MED CORPORATION 510(k) SUBMISSION: NAVIGATOR (Stylet) 03 July, 1997
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Karen K. Sylvia QA/QC Manager Sil-Med® Corporation 700 Warner Boulevard Taunton, Massachusetts 02780
K972521 Re:
Trade Name: Navigator Regulatory Class: I Product Code: GAH Dated: July 3, 1997 Received: July 7, 1997
Dear Ms. Sylvia:
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 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 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 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 (OS) 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.
OCT - 1 1997
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Page 2 - Ms. Karen K. Sylvia
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) 594-4595. 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/dsmamain.html".
Sincerely yours,
Аебева
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Sil-Med Corporation 700 Warner Boulevard Taunton, MA 02780 Date: 3 July, 1997
19725 510(k) Number (if known): Device Name: Navigator (stylet)
Indications For Use:
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The Navigator (stylet) is a stainless steel wire rod, inserted into the catheter to assist with insertion and placement of the catheter in the peritoneum.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use
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(Optional Format 1-2-96)
§ 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.