(139 days)
No
The device description lists only mechanical surgical instruments and accessories, with no mention of software, image processing, or AI/ML terms.
No
The device is used for diagnostic and surgical procedures to visualize and access spinal anatomy, which are typically considered interventional rather than therapeutic in themselves. Therapeutic devices usually deliver a direct therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the system is intended "to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures". The mention of "diagnostic procedures" directly indicates its diagnostic intent.
No
The device description explicitly lists physical components such as cannulas, sheaths, dilators, drills, trephines, forceps, punches, mallet, and guidewires, indicating it is a hardware-based system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for visualizing the inside of the patient through a cannulated incision for diagnostic and surgical procedures. This involves direct interaction with the patient's body during a medical procedure.
- Device Description: The description lists instruments used for accessing and treating spinal anatomy and pathology. These are surgical tools, not devices used to examine samples of bodily fluids or tissues outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is a surgical system used in vivo (within the living body).
N/A
Intended Use / Indications for Use
The maxMorespine System is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as: arthroplasty, nucleotomy, discectomy and foraminotomy.
Product codes
HRX
Device Description
The maxMorespine System consists of basic cannulas, sheaths, dilators, drills, trephines, forceps, punches, mallet and quidewires which facilitate or compliment the maxMorespine Endoscope (submitted separately under K083552). The System is designed to provide the access and treatment of spinal anatomy and pathology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spinal
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)
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
Section 1.0 510(k) Summary
as required by section 807.92(c)
JUN - 9 2009
maxMorespine System
1.1
Submitter Information
Hoogland Spine Products GmbH Feringastr. 7a D-85774 Unterföhring - Germany Phone No .: +40 (0) 89 21 58 960 - 20 +49 (0) 89 21 58 960 - 98 Fax No.:
USA Agent:
Spine Now, LLC 94 Gardiners Ave, #307 Levittown, NY 11756 Phone No .: (888) 994-3335 Fax No.: (516) 277-0065
Contact Information
Joan L. Carter, President, Spine Now, LLC. Phone No.: (516) 721-7442 E-mail: jcarter@spinenow.com
1.2 Establishment / Owner Information
Hoogland Spine Products GmbH Feringastr. 7a D-85774 Unterföhring - Germany
FDA Establishment Registration Number 30065611611
- 1.3 Proprietary Name maxMorespine System
1.4 Common Name Spinal Endoscopy System
1.5 Classification Name Accessories, Arthroscopic .
1.6 Regulation Number 21 CFR 888.1100
1
1.7 Regulatory Class
Class II
- Classification Product Code 1.8 HRX
Intended Use 1.9
The maxMorespine System is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as: arthroplasty, nucleotomy, discectomy and foraminotomy.
1.10 Device Description
The maxMorespine System consists of basic cannulas, sheaths, dilators, drills, trephines, forceps, punches, mallet and quidewires which facilitate or compliment the maxMorespine Endoscope (submitted separately under K083552). The System is designed to provide the access and treatment of spinal anatomy and pathology.
1.11 Substantial Equivalence
The maxMorespine System is substantially equivalent in purpose, design, materials and function to the following marketed products;
-
Joimax THESSYS Multiscope (K051827)
-
RIchard Wolf Yeung Endoscopic Spine System (K973405)
-
Arthro Kinetics' Endoscopic Spine System (K061246)
1.12 Sterilization
With the exception of the Disposable 4mm Manual Bone Drill, maxMorespine System will be sold non-sterile, to be sterilized prior to each procedure by the user. Sterilization instructions are provided in the Instructions for Use (see Section 2.5)
The Disposable Manual Bone Drill will be supplied sterile via Gamma Irradiation (see Bioburden Test Protocol - Section 3.2 and Certificate of Gamma Irradiation - Section 3.3).
1.13 Software
No Software is needed for the maxMorespine System.
1.14 Conclusion
The specifications and intended use of the maxMorespine System is the same as those of the claimed predicate devices. There are no significant differences in design or manufacturing materials between the maxMorespine System and predicate devices. In all aspects, the maxMorespine System is substantially equivalent to products actively marketed as demonstrated in Predicate Devices Comparison Chart (see Section 4.1)
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, vectorized design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hoogland Spine Products GmbH % Mr. Boris Miklitz Arabellastr 4 Muenchen GERMANY D-81925
Re: K090132
Trade/Device Name: maxMorespine System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: May 29, 2009 Received: June 2, 2009
Dear Mr. Miklitz:
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.
JUN - 9 2009
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
3
Page 2-Mr. Boris Miklitz
practice requirements as set torth 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdirh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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.
Sincerely yours,
Mark N. Melkerson
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
maxMorespine System
Indications for Use
510(k) Number; K090132
maxMorespine System Device Name:
Indications for Use:
The maxMorespine System is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures such as; arthroplasty, nucleotomy, discectomy and foraminotomy.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nilreorden Forman
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K090132
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