(191 days)
Not Found
No
The summary describes a mechanical system for discectomy procedures and does not mention any AI or ML components or functionalities.
Yes
The device is described as being used for "ablation and coagulation" of disc material during "discectomy procedures," indicating it performs a therapeutic function.
No
The device is used for ablation and coagulation of intervertebral disc material, which is a therapeutic rather than diagnostic function.
No
The device description explicitly lists multiple physical, disposable components (Trigger-Flex™ Dipolar System, Guidewire, Cannulas, etc.), indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ablation and coagulation of intrervertebral disc material during discectomy procedures in the lumbar spine." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The components listed are surgical instruments (cannulas, dilator, trephine, etc.) used for accessing and manipulating tissue within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The Disc-FXTM System is intended for use in ablation and coagulation of intretervertebral disc material during discectomy procedures in the lumbar spine.
Product codes
HRX, GEI
Device Description
The Disc-FXTM System is a single-use disposable kit that contains the following disposable components:
- Trigger-Flex™ Dipolar System
- Trigger-Flex™ Depth Stop
- Guidewire
- Cannula, Straight
- Cannula, Beveled
- Cannula Depth Stop
- Tapered Dilator
- Trephine
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine
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
Mechanical performance tests were performed for the Ellman Disc-FX™ System to verify the device meets design specifications and intended performance characteristics. Disc-FX 100 components were utilized in multiple discectomy procedures by a doctor skilled in percutaneous and endoscopic spine procedures. A clinical experience summary is provided in Section 5. Ellman has determined, based upon testing/clinical investigation results that the device conforms to its specifications and is at least as safe and effective as the predicate devices for discectomy procedures.
Key Metrics
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
KOS2241
510(k) Summary of Safety and Effectiveness 1.0
This 510(k) safety and effectiveness summary is being submitted in accordance with the start 02 , hills 5 f0(K) Salety and Checaronooo Cammary TSF 1990 and 21 CFR 807.92.
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Company Name and Address: 1.1 Ellman International, Inc. 3333 Royal Avenue Oceanside, NY 11572 Contact Individual: Joan Carter Vice President Jcarter@eliman.com Tel: (516) 267-6522 Fax: (516) 881-3002
Page 1 of 2 -
Disc-FXTM System Proprietary Name: Device Name: 1.2 Electrosurgical Device and Accessories Common / Usual Name
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Electrosurgery Cutting and Coagulation Devices and Accessories Classification: 1.3 (21 CFR 878.4400)
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Device Description: 1.4
The Disc-FXTM System is a single-use disposable kit that contains the following disposable components:
- ng disposable of the Bipolar System
- Trigger-Flex™ Dipolar System
-
Trigger-Flex™ Depth Stop
-
- Guidewire
-
- Cannula, Straight
-
- Cannula, Beveled
-
- Cannula Depth Stop
-
- Tapered Dilator
-
- Trephine
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- Disc-FX™ System is intended for use in ablation and coagulation of Intended Use: 1.5 intrervertebral disc material during discectomy procedures in the lumbar spine.
- Substantial Equivalence 1.6
This 510(k) premarket notification is being submitted for the Ellman This 510(K) premarket notinoation is boling sustem is substantially Disch A - Oyotomintly marketed bipolar electrosurgical (RF probes) equivalent to ourrently cannula, tapered dilator, and and Spiric accounds (garastrals intended use (percutaneous access trephine) doness attervertebral disc tissue) , biomechanical and troutines, and technological characteristics (materials, performation, and toone of operation). A Substantial Equivalence Comparison Chart (Section 4.1) and Predicate Device 510(K) Oompanson Chart (Soct Brochures are included in Section 4.2.
1
052241
Page 2 of 2
Performance Testing: 1.7
Mechanical performance tests were performed for the Ellman Disc-FX™ System to verify the device meets design specifications and intended performance characteristics.
Disc-FX 100 components were utilized in multiple discectomy procedures by a doctor skilled in percutaneous and endoscopic spine procedures. A clinical experience summary is provided in Section 5.
Ellman has determined, based upon testing/clinical investigation results that the device conforms to its specifications and is at least as safe and effective as the predicate devices for discectomy procedures.
- Sterilization: A detailed Sterilization Protocol (Section 3.3) and Validation 1.8 Summary (Section 3.4) are included in this submission which are specific to the Trigger-Flex™ device. As the molded plastic and Stainless Steel components of the Trigger-Flex™ are identical to the materials of other Disc-FXTM components; Guidewire, Cannula's. Tapered Dilator and Trephine, we submit this data for the entire system.
- 1.9 Other Considerations:
a. Electorosurgical Generator - is not part of this 510K submission. Surgitron Surgi-Max Dual Frequency (K001253) unit is intended for use with Disc-FXTM System.
2
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
FEB 2 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ellman International, Inc. c/o Ms. Joan L. Carter Vice President 3333 Royal Avenue Oceanside, New York 11572-3625
Re: K052241 Trade/Device Name: Disc-FXTM System Regulation Number: 21 CFR 888.1100 and 21 CFR 878.4400 Regulation Name: 21 OFFS ps, Elecrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: HRX, GEI Dated: December 28, 2005 Received: December 29, 2005
Dear Ms. Carter:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above und nave active legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been require approval of a premarket approval application (PMA). alle Costlette Act (71ct) that do novice, subject to the general controls provisions of the Act. The rou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls proficits of ractice, 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 it may of Subject to Such additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oour cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r tcase be activities that I DTT o losantes to rour device complies with other requirements of the Act that IDA has made a decemination administered by other Federal agencies. You must or ally it cach statutes and regalations .including, but not limited to: registration and listing (21 Compry with an the Act 31equirements)01); good manufacturing practice requirements as set CI K Fart 607), naoning (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Ms. Carter
This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin manteinig your antial equivalence of your device to a legally premarket notification. The PDA midning of basisand will be 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 If you desire specific advice for your do rise of 115. Also, please note the regulation entitled, and Contact the Office of Comphanee at (210) 210 or on 101 CFR Part 807.97). You may obtain " Misbranding by reletence to premarket noutheanon" (2) " e Act from the Division of Small other general information on your response at its toll-free number (800) 638-204 or Manufacturers, international and Consulter visors and constituentry/support/index.html.
Sincerely yours,
elmee
Mark N. Melkerson, MS
Mark N. Melkerson, M.S. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Disc-FXTM System
Device Name:
Indications for Use:
The Disc-FXTM System is intended for use in ablation and The Disc-I X - Oystem to interial during discectomy procedures in the lumbar spine.
Prescription Use × (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 Evaluations (ODE)
Page 1 of 1
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
KOS2241 510(k) Number.