(86 days)
Not Found
Not Found
No
The device description and intended use clearly describe a simple mechanical stylet made of stainless steel, with no mention of any computational or data-driven features. The lack of any mention of AI, ML, image processing, or performance metrics related to algorithmic output further supports this conclusion.
No.
The device's function is to assist with insertion and placement of a catheter, which is a procedural aid, rather than directly treating a medical condition or restoring a bodily function.
No
The device, a stylet, is described as an aid for inserting and placing a catheter. It does not perform any diagnostic function such as detecting, monitoring, or predicting diseases.
No
The device description clearly states it is a "stainless steel wire rod," which 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 assist with the insertion and placement of a catheter in the peritoneum. This is a procedure performed in vivo (within the living body).
- Device Description: The device is a physical tool (a stainless steel wire rod) used for mechanical manipulation during a surgical or medical procedure.
- Lack of IVD Characteristics: IVDs are devices intended for use in the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a medical device used for a procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GAH
Device Description
Stainless steel wire rod intended to aid in the manipulation of or insertion of the catheter for placement in the peritoneum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneum
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Biocompatability Testing has been conducted. Cytotoxicity Study: Pass. Hemolysis Study - In Vitro: Non-Hemolytic.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Accurate Surgical's Insertion Stylet, Medigroup's Catheter Stylettes, Quinton's Stylet
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
1972521
OCT - 1 1997
510 (k) Summary
| Company: | Sil-Med Corporation
700 Warner Boulevard
Taunton, MA 02780 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone:
Fax: | (508) 823-7701
(508) 823-1438 |
| Contact Person: | Karen K. Sylvia
QA/QC Manager |
| Trade Name: | Navigator |
| Common Name: | Stylet |
| Classification Name: | Introduction/drainage catheter and accessories accessory intended
to 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 or
insertion of the catheter for placement in the peritoneum. |
| Predicate Device: | Accurate Surgical's Insertion Stylet
Medigroup's Catheter Stylettes
Quinton's Stylet |
| Intended Use: | 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. |
Biocompatability Testing:
| Test | Results |
|---|---|
| Cytotoxicity Study | Pass |
| was 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 in | |
| Hemolysis Study - In Vitro | Non-Hemolytic |
| Call 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
1
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
2
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
3
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:
ੱਡ
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)
ecepe
Divisi eral Res 510(k) Numl
Prescription Use
(Per 21 CFR 801.109) X
OR
Over-The-Counter Use
ﺎ
(Optional Format 1-2-96)