(338 days)
Not Found
No
The device description and intended use clearly define the device as a simple light wand for illumination, with no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device is described as being "for illumination only" and its intended use is to provide light during examinations and procedures. It does not state any therapeutic function.
No
The device is explicitly stated to be "for illumination only and is not indicated for viewing." Its purpose is to provide light during procedures, not to diagnose conditions.
No
The device description clearly details physical components such as a stainless steel tube, glass fibers, epoxy, and a stainless steel knob, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The ITALITE tm Light Wand is used for illumination during surgical procedures within the body. It provides light to help the physician see the internal structures.
- Intended Use: The intended use clearly states it's for "illumination during joint examinations, arthroscopies, biopsies, in minimally invasive procedures." This is a surgical/procedural use, not an in vitro diagnostic use.
- Device Description: The description details a physical device designed to transmit light into the body, not to analyze biological samples.
The device is an endoscopic accessory used for visualization during minimally invasive procedures.
N/A
Intended Use / Indications for Use
The ITALITE tm Light Wand is indicated for illumination during joint examinations. arthroscopies, biopsies, in minimally invasive procedures of the knee, shoulder, temporal-mandibular joint, ankle, and elbow.
The ITALITE tm Light Wand is disposable, single use and is intended to be discarded after the procedure. It is supplied clean but not sterile and must be sterilized before use.
The ITALITE tm is for illumination only and is not indicated for viewing. It is to be used by physicians only.
Product codes
HRX
Device Description
The ITALITE tm models of Light Wands range in size as follows:
| MODEL | LENGTH | DIAMETER |
|---|---|---|
| 650-3.1 | 650 mm | 3.1 mm |
| 600-3.1 | 600 mm | 3.1 mm |
| 550-3.1 | 550 mm | 3.1 mm |
| 500-3.1 | 500 mm | 3.1 mm |
| 450-2.0 | 450 mm | 2.0 mm |
| 400-2.0 | 400 mm | 2.0 mm |
The ITALITE tm series of Light Wands are semi rigid type devices which are intended for illumination during joint examinations, biopsies, in minimally invasive procedures of the knee, shoulder, temporal mandibular joint, ankle, and elbow.
The device consists of a thin walled stainless steel tube (either 3.1 mm or 2.0 mm) varying in length from 400 to 650 mm depending on the model number as above. 50 micron glass fibers fill the inner diameter of the tube. At the proximal end the fibers are sealed with epoxy and polished. They are terminated in a light pipe connector compatible with off the shelf light sources such as those manufactured by ACMI, Wolff, Stortz, and Olympus. A stainless steel knob at the proximal end facilitates the direction and placement of the Light Wand.
The distal end of the Light Wand has a window perpendicular to the shaft where the fibers terminate. They are epoxied and polished to form a window perpendicular to the shaft. Hence the light is directed perpendicular to the shaft and provides illumination in that direction instead of head on from the end of the Light Wand.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, temporal-mandibular joint, ankle, and elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians only.
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)
Performance tests designed to ensure that the device met all of its functional specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards.
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
K07-0021
Pg 1 of 5
ITALITE tm 510k JG Medical Products LLC
510K SUMMARY OF SAFETY AND EFFECTIVENESS
0EC 17 2007
This summary of 510k safety and effectiveness information is being submitted in accordance with 21CFR part 807.92
- Submitters name, address, phone number, contact person and preparation date:
| Name: JG Medical Products LLC. | ||||
|---|---|---|---|---|
| 110 E. Main Street, Suite 7 | ||||
| Huntington, N.Y. 11743 | ||||
| Phone: 631 673 5255 | ||||
| Fax: 631 673 4949 | ||||
| Email: wstern@multigon.com | ||||
| Responsible person: William Stern | ||||
| Official correspondent: | ||||
| William Stern | ||||
| Multigon Industries, Inc. | ||||
| 1 Odell Plaza | ||||
| Yonkers, N.Y. 10701 | ||||
| Phone: 914 376 5200 ext. 27 | ||||
| Fax: 914 376 6111 | ||||
| Email: wstern@multigon.com | ||||
| Date of Preparation: | ||||
| 12/5/07 | ||||
| 2. Proprietary Name: | ||||
| ITALITE tm Models: | ||||
| 500-3.1 | ||||
| 550-3.1 | ||||
| 600-3.1 | ||||
| 650-3.1 | ||||
| 450-2.0 | ||||
| 400-2.0 | ||||
| Common /Usual Name: | ||||
| Arthroscope | ||||
1
Pg 2 of 5
ITALITE tm 510k JG Medical Products LLC
Classification Name: 21 CFR888.1100 Arthroscopes
Classification Number: 90HRX
- Substantially Equivalent Devices
JG Medical Products LLC believes that the ITALITE tm light wand Models 500-3.1; 550-3.1; 600-3.1; 650-3.1; 450-2.0; 400-2.0 is substantially equivalent to the following cleared devices:
| Trade or Proprietary Name | Manufacturer | 510(k) Number |
|---|---|---|
| Medscope 4mm Arthroscope | Medscope Corp. | K894303 |
| ASAP Arthroscope | ASAP Endoscopic Products | K031972 |
All of the above predicate Arthroscopes have two fiber optic channels, one for viewing and one for illuminating the subject field. The ITALITE tm light wand models above are made of similar materials, fibers, and epoxies.to the predicate devices above. In fact the ITALITE tm light wand uses exactly the same materials and construction methods as the Medscope 4mm Arthroscope K894303, However the ITALITE tm light wand Models have only an illumination channel and are not used for viewing. Illumination is perpendicular to the shaft. Substantial equivalence is claimed for the indications for use for this application.
2
P) 3 21-5
ITALITE tm 510k JG Medical Products LLC
4. DEVICE DESCRIPTION
The ITALITE tm models of Light Wands range in size as follows:
| MODEL | LENGTH | DIAMETER |
|---|---|---|
| 650-3.1 | 650 mm | 3.1 mm |
| 600-3.1 | 600 mm | 3.1 mm |
| 550-3.1 | 550 mm | 3.1 mm |
| 500-3.1 | 500 mm | 3.1 mm |
| 450-2.0 | 450 mm | 2.0 mm |
| 400-2.0 | 400 mm | 2.0 mm |
The ITALITE tm series of Light Wands are semi rigid type devices which are intended for illumination during joint examinations, biopsies, in minimally invasive procedures of the knee, shoulder, temporal mandibular joint, ankle, and elbow.
The device consists of a thin walled stainless steel tube (either 3.1 mm or 2.0 mm) varying in length from 400 to 650 mm depending on the model number as above. 50 micron glass fibers fill the inner diameter of the tube. At the proximal end the fibers are sealed with epoxy and polished. They are terminated in a light pipe connector compatible with off the shelf light sources such as those manufactured by ACMI, Wolff, Stortz, and Olympus. A stainless steel knob at the proximal end facilitates the direction and placement of the Light Wand.
The distal end of the Light Wand has a window perpendicular to the shaft where the fibers terminate. They are epoxied and polished to form a window perpendicular to the shaft. Hence the light is directed perpendicular to the shaft and provides illumination in that direction instead of head on from the end of the Light Wand.
3
K070021 pg 4 of 5
ITALITE tm 510k JG Medical Products LLC
5. PERFORMANCE STANDARDS
No performance standards have been established for the ITALITE tm Light Wands under section 514 of the Federal Food and Drug Act. However the ITALITE tm Light Wands have been designed to meet the following standards:
Applicable portions of IEC60601-2-18 Manufacturing under an approved Quality System
6. INDICATIONS FOR USE
The ITALITE tm Light Wand is indicated for illumination during joint examinations, arthroscopies, biopsies, in minimally invasive procedures of the knee, shoulder, temporalmandibular joint, ankle, and elbow .
The ITALITE tm Light Wand is disposable, single use and is intended to be discarded after the procedure. It is supplied clean but not sterile and must be sterilized before use.
The ITALITE tm is for illumination only and is not indicated for
viewing.
It is to be used by physicians only.
7. CONTRA-INDICATIONS
None known at this time.
8. COMPARISON TO PREDICATE DEVICES
The ITALITE tm series of Light Wands have the same device characteristics as the approved predicate devices listed in item 3 above with the commonality of the illumination modality . principles of operation, and materials.
4
KOFOD'S
105 of
ITALITE tm 510k JG Medical Products LLC
The ITALITE tm series of Light Wands are constructed of materials of the same specifications as the predicate devices to ensure biocompatibility. The ITALITE tm Light Wands conforms to applicable ISO standards. The device will be sold non-sterilized before use by the user. The ability to sterilize the device has been confirmed by the recommended sterilization validation protocol.
Performance tests designed to ensure that the device met all of its functional specifications. Safety tests have been performed to ensure the device complies with applicable industry and safety standards.
The ITALITE tm Light Wand series device labeling includes instructions for safe and effective use, warnings, cautions and guidance for use. It has therefore shown to be safe and effective.
9. SOFTWARE
The ITALITE tm series of Light Wands have no software or firmware associated with them.
10. LITERATURE REVIEW
A review of the literature pertaining to the safety and effectiveness of the ITALITE tm Arthroscopes has been conducted and appropriate safeguards have been incorporated in the design of the ITALITE tm Light Wands.
11. CONCLUSIONS
The conclusion drawn from these tests is that the ITALITE tm Light Wands are substantially equivalent in safety and efficacy to the predicate devices listed in item 3 above.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JG Medical Products, LLC % Multigon Industries, Inc. William Stern Official Correspondent l Odell Plaza Yonkers, New York 10701
DEC 7 2007
Re: K070021
Trade/Device Name: ITALITE™ Model 500-3.1, 550.3.1, 600-3.1, 650-3.1, 450-2.0 Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 28, 2007 Received: November 30, 2007
Dear Mr. Stern:
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. Iisting 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.
6
Page 2 - Mr. William Stern
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 N Millham
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
K070021 pg 1 of 1
ITALITE tm 510k JG Medical Products LLC
32
Indications for Use
510(k) Number (if known): K070021 TM Device Name: ITALITE LIGHT WAND
Indications For Use:
The ITALITE tm Light Wand is indicated for illumination during joint examinations. arthroscopies, biopsies, in minimally invasive procedures of the knee, shoulder, temporal-mandibular joint, ankle, and elbow.
The ITALITE tm Light Wand is disposable, single use and is intended to be discarded after the procedure. It is supplied clean but not sterile and must be sterilized before use.
The ITALITE tm is for illumination only and is not indicated for viewing. It is
to be used by physicians only.
Prescription Use AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CD®1vigfiga aff and Neurological Device
510(k) Number |
$$k$$
070021|
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