The asap multiscope 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.

Device Description

The asap multiscope is a rigid or semiflex-type multi-channel endoscope provided with a rod lens system to transmit light and images, a working channel and one or two irrigation channel(s) and stopcocks. The body consists 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, the working channel and the irrigation/suction channel(s). The eyepiece and light post are adaptable to standard endoscopic cameras and light systems. The endoscope is intended for use with standard working sheaths (cannulas) for minimally invasive access. Accessories include working sheaths, spinal needles, guide wire, dilators, trephine, hammers, trocars, forceps, and rongeurs, as well as cleaning brushes, a rubber sealing cap, spare O-rings, and a protection sheath.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the asap multiscope device:

This 510(k) summary for the asap multiscope is a Substantial Equivalence (SE) premarket notification. This means the manufacturer is asserting their device is as safe and effective as existing legally marketed predicate devices, rather than demonstrating novel performance against pre-defined criteria. Therefore, the information you're requesting regarding acceptance criteria, specific performance metrics, and detailed study parameters (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, and human reader studies) is typically not provided in this type of submission, as it's not required for a SE determination.

The core of the submission revolves around demonstrating that the asap multiscope is substantially equivalent to its predicate devices (Joimax Tessys Multiscope, Arthro Kinetics Endoscopic Spine System, and maxMorespine Endoscope).

Here's an attempt to address your points based on the provided text, highlighting where information is absent or inferred due to the nature of a 510(k) SE submission:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Claim)

Since this is a Substantial Equivalence submission, the "acceptance criteria" are generally that the device performs at least as well as and has no significant differences in safety or effectiveness compared to the predicate devices. The "reported device performance" is essentially that it meets this standard.

Acceptance Criteria	Reported Device Performance
Performance specifications and intended use are the same as predicate devices.	"Specifications and intended use of the asap multiscope are the same as those of the predicate devices."
No significant differences in design or usage conditions compared to predicate devices.	"There are no significant differences between the asap multiscope and the predicates in design or usage conditions."
Materials are identical to those of the predicate devices, ensuring high performance and biocompatibility.	"Materials are identical to those of the predicate devices, ensuring high performance and biocompatibility."
Recommended cleaning and sterilization processes are validated.	"The recommended cleaning and sterilization processes have been validated."
Meets applicable safety standards for endoscopic equipment.	"Performance testing was conducted according to the applicable sections of standard IEC 60601-2-18. Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment."
Overall, safe and effective, and substantially equivalent to predicate devices.	"The information provided in this 510(k) submission provides reasonable assurance that the asap multiscope is safe and effective and that it is substantially equivalent to the predicate devices with respect to intended use and technological characteristics."

Here's a breakdown of the specific points you requested, with indications of what is and isn't available in this 510(k) summary:

A table of acceptance criteria and the reported device performance:
- See the table above. The "acceptance criteria" for a 510(k) SE typically revolve around demonstrating equivalency to known safe and effective predicate devices, rather than meeting specific quantifiable performance thresholds for clinical accuracy or efficacy.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. This type of detail is not required or typically included in a 510(k) SE submission for a device like an endoscope, where the primary demonstration is mechanical and material equivalence and adherence to recognized safety standards. The "performance data" mentioned refers to testing against safety standards and validation of sterilization, not clinical performance with a specific patient dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. Since there's no clinical "test set" in the sense of patient data being evaluated for diagnostic or therapeutic accuracy, there's no ground truth established by experts in this context. The "truth" being established is that the device meets engineering specifications and safety standards and is comparable to predicates.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As with point 3, there's no clinical test set requiring adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, not done. This device is an endoscope, a visualization and access tool, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and AI improvement effect size are irrelevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, not applicable. This device is a manual, physical tool; it does not involve any algorithms.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is its adherence to engineering specifications, material biocompatibility, and validated sterilization processes, and its equivalence to legally marketed predicate devices. This is established through bench testing and documentation of material properties and manufacturing processes, not clinical outcomes or expert consensus on patient data.
The sample size for the training set:
- Not applicable/Not provided. There is no "training set" as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable/Not provided. There is no "training set."

In summary:

This 510(k) notification for the asap multiscope is a prime example of a Substantial Equivalence (SE) submission for a traditional medical device (an endoscope). The "study" mentioned primarily refers to:

Engineering and material testing to ensure the device meets its own specifications (which are asserted to be similar to predicates).
Biocompatibility testing of materials (by stating they are "identical to those of the predicate devices").
Validation of cleaning and sterilization processes.
Compliance with recognized industry safety standards (IEC 60601-2-18).

The crucial point is that for a 510(k) of this nature, the manufacturer does not perform independent clinical studies to demonstrate new safety or effectiveness. Instead, they demonstrate that their device is substantially equivalent to existing devices that have already been deemed safe and effective by the FDA. Therefore, detailed clinical performance metrics, sample sizes for patient data, expert reviews, or AI-related study details are not part of this type of submission.

Summary

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K121261

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information

5.1 Applicant:

asap endoscopic products GmbH Stöckmatten 19 79224 Umkirch / Germany

Phone: +49.7665.947 73-0 +49.7665.947 7311 Fax: Email: info@asap-gmbh.de Contact Person : Horst Baholzer

5.2 Device Identification

Trade name: asap multiscope

Common name: Spinal Endoscope

Classification Name: Arthroscope and Accessoires (21 CFR 888.1100; Product Code HRX)

5.3 Predicate Devices

K051827: Joimax Tessys Multiscope

K061246: Arthro Kinetics Endoscopic Spine System

K083552: maxMorespine Endoscope

5.4 Description of Device

5.5 Indications for Use

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ETOS & C VAL

5.6 Technological Characteristics

The asap multiscope is a multi-channel endoscope used to visualize the operative site and provided with a working channel and irrigation channel(s). It is a rigid or semiflex-type endoscope consisting of three basic components through which light is projected into the operation site and a video image is produced on an external video . The asap multiscope has a snap coupler or smart lock connector enabling replacement of the eyepiece by a standard camera.

Performance Data 5.7

Specifications and intended use of the asap multiscope are the same as those of the predicate devices. There are no significant differences between the asap multiscope and the predicates in design or usage conditions. Materials are identical to those of the predicate devices, ensuring high performance and biocompatibility.

The device will be sold non-sterile for steam sterilization by the user. The recommended cleaning and sterilization processes have been validated.

Performance testing was conducted according to the applicable sections of standard IEC 60601-2-18. Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Endoscopic Equipment.

5.8 Conclusions

The information provided in this 510(k) submission provides reasonable assurance that the asap multiscope is safe and effective and that it is substantially equivalent to the predicate devices with respect to intended use and technological characteristics.

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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 or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

ASAP Endoscopic Products GMBH % Business Support International Ms. Angelika Scherp Regulatory Affairs Consultant Amstel 320-I Amsterdam, Netherlands 1017AP

Re: K121261

Trade/Device Name: asap multiscope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: November 02, 2012 Received: November 05, 2012

Dear Ms. Scherp:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

January 8, 2013

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k): asap multiscopes

Indications for Use

510(k) Number (if known): K121261

Device Name: asap multiscopes

Indications for Use:

The asap multiscope is intended to visualize the inside of the patient through a cannulated incision for diagnostic and surgical procedures, such as arthroplasty, nucleotomy, and foraminotomy.

Prescription Use __ X

ANDY

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

AND/OR

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwight Yen 2013.01.07 13:29:56 -05'00'

(Division Sign-Off)

Division of Surgical Devices

510(k) Number __ K121261

Regulation Number and Section

§ 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.