(18 days)
Not Found
No
The description focuses on the mechanical articulation and cutting action of the device, with no mention of AI or ML.
No
The device is described as an articulating soft tissue resector used as an accessory to remove tissue, which is a surgical tool rather than a device intended for therapy or treatment.
No
Explanation: The device is described as a "soft tissue resector" for performing "percutaneous lumbar discectomies." Its function involves cutting and removing tissue, and there is no mention of it being used to identify or predict disease, monitor physiological processes, or provide information for diagnosis.
No
The device description clearly describes a physical, disposable surgical instrument with mechanical components (flexible portion, inner/outer shafts, lever, handle) for cutting and suctioning tissue. It is an accessory to a hardware system.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "soft tissue resector designed to be used as an accessory... to perform percutaneous lumbar discectomies." This describes a surgical tool used in vivo (within the body) to remove tissue.
- Device Description: The description details the mechanical action of the device (rotating inner shaft, cutting aperture, suction) and its use in a surgical procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device is a surgical instrument used directly on the patient's tissue during a procedure.
N/A
Intended Use / Indications for Use
The Endius® FlexTip® Blade is an articulating soft tissue resector designed to be used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible drive system, to perform percutaneous lumbar discectomies.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The Endius FlexTip Blade is a disposable, articulating soft tissue resector designed to be used as an accessory to the Arthroscopic Micro-Discectomy (AMD) System or compatible drive systems. The FlexTip Blade has a flexible portion near the tip, allowing the tip to articulate under control of the lever in the handle. The inner shaft rotates inside the outer shaft providing cutting action through an aperture at the tip. Resected material is suctioned through the inner shaft and shaver handle into an inline external tissue trap. The Endius FlexTip Blade is sold sterile for single-use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar
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)
Not Found
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.
Endius Endo-Bend Shaver System: K950054
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
§ 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
Endius, Inc. Endius® FlexTip™ Blade
08 0
AUG 2 3 2002
Section 7 - 510(k) Summary
| 7.1
Statement | Pursuant to §513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Endius, Inc. is
required to submit with this Premarket Notification either an "... adequate
summary of any information respecting safety and effectiveness or state that
such information will be made available upon request of any person." Endius,
Inc. chooses to submit a summary of information respecting safety and
effectiveness. According to §513(i)(3)(B), "Any summary under subparagraph
(A) respecting a device shall contain detailed information regarding data
concerning adverse health effects..."
The summary regarding the adverse health effects of the modified device,
Endius® FlexTip® Blade is provided below. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 7.2
Submitter | Endius, Inc.
23 West Bacon Street
Plainville, MA. 02762 |
| 7.3
Company
Contact | Christine Kuntz-Nassif
Director, Regulatory Affairs
508-643-0983 Ext. 114 |
| 7.4
Device
Name | Proprietary Name:
Endius® FlexTip® Blade
Common Name:
Arthroscopic Accessory: Bendable Shaver
Classification Name:
Arthroscope (HRX) |
| 7.5
Predicate
Device | Endius Endo-Bend Shaver System: K950054 |
| 7.6
Device
Description | The Endius FlexTip Blade is a disposable, articulating soft tissue resector
designed to be used as an accessory to the Arthroscopic Micro-Discectomy
(AMD) System or compatible drive systems. The FlexTip Blade has a flexible
portion near the tip, allowing the tip to articulate under control of the lever in
the handle. The inner shaft rotates inside the outer shaft providing cutting
action through an aperture at the tip. Resected material is suctioned through the
inner shaft and shaver handle into an inline external tissue trap. The Endius
FlexTip Blade is sold sterile for single-use only. |
| 7.7
Device
Indications
For Use | The Endius® FlexTip® Bladeis an articulating soft tissue resector designed to be
used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an
equivalent and compatible drive system, to perform percutaneous lumbar
discectomies. |
| 7.8
Substantial
Equivalence | The proposed Endius FlexTip BladeSystem is substantially equivalent to the
Endius Endo-Bend System, K950054. |
1
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized, curved lines that resemble a person. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2002
Endius, Inc. Christine Kuntz-Nassif Director, Regulatory Affairs 23 West Bacon Street Plainville, Massachusetts 02762
Re: K022578
Trade/Device Name: Endius® Flextip® Blade Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: August 2, 2002 Received: August 5, 2002
Dear Ms. Kuntz-Nassif:
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.
3
Page 2 - Ms. Christine Kuntz-Nassif
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N Milken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Endius® FlexTip® Blade
Indications for Use:
The Endius® FlexTip® Blade is an articulating soft tissue resector designed to be used as an accessory to an Arthroscopic Micro-discectomy (AMD) system or an equivalent and compatible drive system, to perform percutaneous lumbar discectomies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurence of CDRH, Office of Device Evaluation (ODE)
(Posted July 1, 1998)
. ......... ..................................................................................................................................................................
(Optional Format 3-10-98)
Mark A. Milliman
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number -