(90 days)
Not Found
No
The summary describes a mechanical endoscope with optical components and instruments. There is no mention of software, image processing, or any terms related to AI/ML.
Yes
The device's intended use explicitly states "diagnostic and/or therapeutic neuroendoscopy" and lists activities like "ventriculostomies, biopsies and removal of cysts, tumors and other obstructions," which are therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "direct visualization, diagnostic and/or therapeutic neuroendoscopy". This indicates its use in diagnostic procedures.
No
The device description clearly outlines physical components like a rigid neuroendoscope, flexible parts, operating channels, prisms, and micro-instruments, indicating it is a hardware device.
Based on the provided information, the Aesculap's Paediscope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "direct visualization, diagnostic and/or therapeutic neuroendoscopy." This involves directly visualizing and manipulating tissues within the body, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The description details a surgical instrument used for internal procedures, including visualization, cutting, and grasping. This aligns with a surgical or diagnostic instrument used in vivo, not an IVD device used in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any of the typical components or processes associated with IVD testing.
Therefore, the Aesculap's Paediscope is a medical device used for surgical and diagnostic procedures within the body, not an IVD device.
N/A
Intended Use / Indications for Use
Aesculap's Paediscope is intended for use in endoscope-assisted microneurosurgery and pure Aesoulap 3 Paculoope io intendopy) for direct visualization, diagnostic and/or therapeutic noaroonaooopy (nor retriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Product codes
84 GWG, 84 GZX
Device Description
Aesoulap's Paediscope combines the features of both flexible and rigid scopes. The distal end is a rigid neuroendoscope with a 3.0mm diameter. The rigid part includes one operating channel and nga nedrochaooops with a oroni. The flexible part ends at the standard adapters for light cables and eyepiece connection. The flexible outpatient part allows more flexibility and reduces the weight af the scope part introduced into the patient. The Paediscope can be used in adult and pediatric or the soope part introduced this the patts are included with the Paediscope for the cutting and grasping biopsies and the removal of cysts, tumors and other obstructions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric
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)
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Paediscope comply with the requirements of IEC60601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.) The Paediscope has undergone evaluation for electrical, thermal and irrigation safety to ensure the system is safe for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K983365, K954394, K954899, K002572, K002704
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
MAR 1 8 2002
in Accordance with SMDA of 1990
PAEDISCOPE
Kol 4149 1/3
December 12, 2001
| COMPANY: | Aesculap ®, Inc.
3773 Corporate Parkway
Center Valley, PA 18034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Georg Keller, Regulatory Affairs Manager
800-258-1946 (phone)
610-791-6882 (fax)
georg.keller@aesculap.com (email) |
| TRADE NAME: | Paediscope |
| COMMON NAME: | Neuroendoscope |
| DEVICE CLASS: | NEUROENDOSCOPE CLASS II
MICRO-INSTRUMENTS – CLASS I EXEMPT |
| PRODUCT CODE: | Neuroendoscope - 84 GWG
Micro-Instruments - 84 GZX |
| CLASSIFICATION: | Neuroendoscope - 882.1480
Micro-Instruments - 882.4525 |
| REVIEW PANEL: | Neurology |
INTENDED USE
Aesculap's Paediscope is intended for use in endoscope-assisted microneurosurgery and pure Aesoulap 3 Paculoope io intendopy) for direct visualization, diagnostic and/or therapeutic noaroonaooopy (nor retriculostomies, biopsies and removal of cysts, tumors and other obstructions.
DEVICE DESCRIPTION
Aesoulap's Paediscope combines the features of both flexible and rigid scopes. The distal end is a rigid neuroendoscope with a 3.0mm diameter. The rigid part includes one operating channel and nga nedrochaooops with a oroni. The flexible part ends at the standard adapters for light cables and eyepiece connection. The flexible outpatient part allows more flexibility and reduces the weight af the scope part introduced into the patient. The Paediscope can be used in adult and pediatric or the soope part introduced this the patts are included with the Paediscope for the cutting and grasping biopsies and the removal of cysts, tumors and other obstructions.
PURPOSE FOR SUBMISSION
The purpose for this submission is to gain marketing clearance for the Paediscope.
PERFORMANCE DATA
No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, Aesculap's Paediscope comply with the requirements of IEC60601-2-18 (Medical electrical equipment, Part 2: Particular requirements for the safety of endoscopic equipment.) The Paediscope has undergone evaluation for electrical, thermal and irrigation safety to ensure the system is safe for the intended use.
1
K014149 2/2
SUBSTANTIAL EQUIVALENCE
The new Paediscope described in this premarket notification is substantially equivalent to those predicate devices:
- Aesculap MINOP System (K983365) .
- Aesculap Ventriculoscope System (K954394) .
- Neuro Navigational Neuroview (K954899) .
- Medtronic PSMedical Channel Neuroscope (K002572) .
- Storz Miniature Neuroendoscope (K002704) .
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 the top half of the circle. Inside the circle is a stylized symbol that resembles a caduceus, with three abstract human profiles facing right, suggesting a focus on health and human well-being.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 8 2002
Mr. Georg Keller Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034
Re: K014149
Trade/Device Name: Paediscope Regulation Number: 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: December 15, 2001 Received: December 18, 2001
Dear Mr. Keller:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nove ro roved your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of 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 r ou may, dierely mixes 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 If your device 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 cormply 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 – Mr. Georg Keller
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with a a your a finding of substantial equivalence of your device to a legally premated 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" (21CFR 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,
Miriam C. Provost
for 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
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
014149
Device Name: Paediscope
Indication for Use:
Aesculap's Paediscope is intended for use in endoscope-assisted microneurosurgery Aesculap's Paediscope is Intended for use in officalization, diagnostic and/or and pure neuroendoscopy (t.e. Ventriculosopy) for direct neather in and removal of cysts, tumors and other obstructions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Miriam C. Provost | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative | |
| and Neurological Devices | |
| 510(k) Number | K014149 |
| Prescription Use | or Over-the-Counter Use |
|---|---|
| (per 21 CFR 801.109) |
(Optional Format 3-10-98)