(81 days)
No
The 510(k) summary describes a rigid arthroscope with a traditional optical system (rod-lens system) and light guide. There is no mention of any software, image processing, AI, or ML capabilities. The device description focuses on the physical components and design, comparing it to legally available devices with similar basic designs.
No.
The device is used for illumination during joint examinations, arthroscopies, biopsies, and diagnosis of joint disease, which are diagnostic or procedural assistance, not direct treatment.
Yes
The Intended Use / Indications for Use section explicitly states that the asap arthroscope is indicated for "diagnosis of joint disease".
No
The device description clearly states it is a rigid type endoscope made of surgical steel with physical components like an eyepiece, body, light guide, and rod-lens system, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The asap arthroscope is a medical device used for direct visualization inside joints during surgical procedures. It illuminates the joint and allows the physician to see the internal structures.
- Intended Use: The intended use clearly states it's for "illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures." This involves direct observation and potentially taking tissue samples during a procedure, not analyzing samples outside the body.
The device is an arthroscope, which is a type of endoscope used for minimally invasive joint surgery and examination. This falls under the category of surgical instruments and visualization devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Like the predicate device, the asap arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.
The asap arthroscope is reusable.
The intended use for the asap arthroscope is -- as prescribed in the manufacturers Instructions For Use -- according to relevant medical indication by trained physicians only.
Product codes
HRX
Device Description
The asap arthroscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap arthroscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light quide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joint, knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained 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)
The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol.
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
asap arthroscope
2
KO31972 Pg I of 510(k) Summary of safety and effectiveness
Applicant:
asap endoscopic products GmbH Tullastr. 87 a 79108 Freiburg / Germany
Contact:
Dr. Martina Günderoth C.R.C. Partnerschaftsgesellschaft Katharinenstr. 5 23554 Lübeck, Germany
Phone: +49 (451) 388 2864 Fax: +49 (451) 388 2867 Email: crc@crc-online.de
Device name
Arthroscope, Types:
10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, 10-0006-00, 10-0007-00, 10-0008-00, 10-0009-00, 10-0091-00, 10-0010-00, 10-0011-00, 10-0085-00, 10-0012-00
Common name
Arthroscope
Predicate device name
- AMO Arthroscope (K962330)
Code of Federal Regulations (CFR) number
888.1100
General device description
The asap arthroscope is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap arthroscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light quide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
Indications for use
Like the predicate device, the asap arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally
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K031972 pg 2 of 2
invasive procedures of the knee, shoulder, wrist (carpal tunnel syndrome), temporal mandibular joint, ankle and elbow.
The asap arthroscope is reusable.
The intended use for the asap arthroscope is -- as prescribed in the manufacturers Instructions For Use -- according to relevant medical indication by trained physicians only.
Voluntary standard compliance
The asap arthroscope complies with
- applicable portions of voluntary standards IEC 60601-2-18
- DIN 58105, part 1 and 2
- DIN 17442 (medical steel), as well as applicable portions of
- DIN 980
Substantially equivalence - Safety and effectiveness
The specifications and intended use of the asap arthroscope are the same to those of the claimed predicate devices. There are no significant differences between the asap arthroscope and the claimed predicates in design or conditions of intended use.
The asap arthroscope is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility. The asap arthroscope conforms to applicable ISO standards.
The device will be sold non-sterile, to be sterilized prior to each procedure by the user. The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol.
Conclusion
In all respects, the asap arthroscope is substantially equivalent to one or more rigid endoscopes currently marketed in the USA. It is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility and it conforms to applicable ISO standards.
The ability to repeatedly adequately sterilize the asap arthroscope has been confirmed by validation protocol.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 5 2003
Dr. Martina Günderoth Regulatory Affairs Manager ASAP Endoscopic Products GmbH c/o CRC Katharinenstr. 5 23554 Lübeck, Germany
Re: K031972
Trade/Device Name: Arthroscopes, Ty
Trade/Device Name: Arthroscopes, Types: 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00.10-0006-00.10-0007-00.10-0008-00. 10-0009-00, 10-0091-00, 10-0010-00, 10-0011-00, 10-0085-00, 10-0012-00
Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: June 18, 2003 Received: July 1, 2003
Dear Dr. Günderoth:
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 (OS) 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 - Dr. Martina Günderoth
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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Miriam C. Provost
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
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Page 1 of 1
510(k) Number (if known): K031972
Device Name: asap arthroscope
10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00, Types: 10-0006-00, 10-0007-00, 10-0008-00, 10-0009-00, 10-0091-00, 10-0010-00, 10-0011-00, 10-0085-00, 10-0012-00
Indications For Use:
1000円 0.000円 2000円 0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
The asap arthroscope is indicated for illumination during joint examinations, arthroscopies, biopsies and diagnosis of joint disease in minimally invasive procedures of the knee, shoulder, wrlst (carpal tunnel syndrome), temporal-mandibular joint, ankle and elbow.
The asap arthroscope is reusable and has to be sterilized prior to each procedure by the user.
The intended use for the asap arthroscope is according to relevant medical indication by trained physicians only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter-Use
(Per 21 CFR 801.109)
(Optional Format 3-10-98)
Miriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number K031972