(432 days)
No
The device description focuses on mechanical and electrical components (motor, blade, pump) and does not mention any AI/ML capabilities or data processing for decision-making. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as being used for the "mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology," which is a therapeutic intervention.
No
The device is described as a surgical tool used for mechanical morcellation and removal of prostate tissue, not for diagnosis.
No
The device description clearly outlines hardware components including a handpiece, blade, DC motor, motor driver PCB, aspiration tube set, and peristaltic aspiration pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical morcellation and removal of prostate tissue during an endoscopic surgical procedure. This is a surgical tool used in vivo (within the body) to manipulate tissue.
- Device Description: The description details a mechanical device with a blade, motor, and aspiration system for physically processing tissue. It does not involve analyzing biological samples in vitro (outside the body) to diagnose a condition.
- Lack of IVD Characteristics: IVD devices typically involve reagents, assays, or analytical methods to detect or measure substances in biological samples (like blood, urine, tissue biopsies after removal). This device does not perform any such analysis.
The MultiCut Solo Morcellator is a surgical instrument used for tissue removal during a procedure, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.
Product codes
GCJ
Device Description
The MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facility/hospital environment.
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 following performance data were applied in support of the substantial equivalence determination:
- . EN 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 62304: Medical Device Software - Software life cycle processes
- . ISO 14971: Medical devices - Applications of risk management to medical devices
- . IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- . Comparative bench testing has been performed to show the performance equivalence of the subject device to its predicate
Biocompatibility testing was also conducted for the MultiCut Blades in accordance with:
- EN/ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-18: Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
- ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Software verification and validation testing was conducted, and documentation is provided in this submission, as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The MultiCut Solo System passed all of the required testing and is in compliance with all applicable sections of the above-mentioned performance standards.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2023
Asclepion Laser Technologies GmbH Tom Gruender Regulatory Affairs Manager Bruesseler Strasse 10 Jena. Thuringia 07747 Germany
Re: K213597 Trade/Device Name: MultiCut Solo Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: GCJ Dated: December 14, 2022 Received: December 19, 2022
Dear Tom Gruender:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino -S
Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213597
Device Name MultiCut Solo
Indications for Use (Describe)
The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
5. 510(K) SUMMARY
| Applicant /
Manufacturer
Name and Address: | Asclepion Laser Technologies GmbH
Bruesseler Strasse 10
07745 Jena
Germany |
|--------------------------------------------------|-------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Tom Gruender
Regulatory Affairs Manager
Asclepion Laser Technologies |
| | Email: tom.gruender@asclepion.com
Phone: +49-03641-7700 201
Fax: +49-03641-7700 102 |
| Date Prepared: | 13th January 2023 |
| Common Name: | Soft Tissue Morcellator and Accessories |
| Device Name: | MultiCut Solo |
| Regulatory Class: | Class II |
| Regulation Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | GCJ |
| Basis for Submission: | new submission |
| Predicate Devices: | VersaCut + Morcellator (K133272)
MORCE SCOPE SET 8970 (K041610) |
Performance Standards:
There are no mandatory performance standards for this device.
4
Description of the device:
The MultiCut Solo consists of a special endoscopic handpiece in which a blade is inserted which mechanically shreds the tissue. The blade is driven by a dc motor, which is integrated in the handpiece. The motor itself is driven by a motor driver PCB. The blade can rotate at different speeds and thereby change the direction of rotation periodically (so called oscillation). The morcellator handpiece is also connected by an aspiration tube set to a peristaltic aspiration pump. By this pump the crushed tissue can be transported through a hollow channel in the handpiece to a waste container.
Other characteristics:
The device includes a controlling software.
The device has patient contacting material made of stainless steel which has short term contact (limited contact) with body tissue (External Communicating Device).
The patient contacting components are supplied non-sterile and are intended to be cleaned, disinfected and steam sterilized before the first use and after any following re-use.
The device is intended to solely be used in healthcare facility/hospital environment.
Indications for Use
The MultiCut Solo Morcellator is intended for use under endoscopic visualization for the transurethral mechanical morcellation and removal of the adenoma after enucleation of the prostate during endoscopic surgical procedures in urology.
Nonclinical Performance Data:
The following performance data were applied in support of the substantial equivalence determination:
- . EN 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 62304: Medical Device Software - Software life cycle processes
- . ISO 14971: Medical devices - Applications of risk management to medical devices
- . IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment
- . Comparative bench testing has been performed to show the performance equivalence of the subject device to its predicate
Biocompatibility testing was also conducted for the MultiCut Blades in accordance with:
- EN/ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-18: Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process
- ISO 10993-11 Biological evaluation of medical devices Part 11: Tests for systemic toxicity ●
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
5
Software verification and validation testing was conducted, and documentation is provided in this submission, as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The MultiCut Solo System passed all of the required testing and is in compliance with all applicable sections of the above-mentioned performance standards.
| | Primary Predicate
Device | Secondary Predicate
Device | Subject Device |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model Name | VersaCut + Morcellator | MORCE SCOPE SET 8970 | MultiCut Solo |
| Manufacturer | Lumenis LTD | RICHARD WOLF MEDICAL
INSTRUMENTS CORP. | Asclepion Laser
Technologies GmbH |
| 510(k) | K133272 | K041610 | - |
| Principal of
Operation | Morcellation through
the cutting effect of
the cutting window,
produced by the
relative movement of
the internal tube and
the external tube. | Morcellation through the cutting
effect of the cutting window,
produced by the relative movement of
the internal tube and the external
tube. | Morcellation through
the cutting effect of the
cutting window,
produced by the relative
movement of the
internal tube and the
external tube. |
| Intended Use | The VersaCut + Tissue
Morcellator is
intended for use under
direct or endoscopic
visualization for the
morcellation and
removal
of dissected tissue
during
pelviscopic,
laparascopic,
percutaneous and
open surgical
procedures
whenever access to
the surgical site is
limited. | Morce Scope Set 8970, in conjunction
with a morcellation probe, and with its
sheaths and obturators, is used in the
cutting (morcellation) and continuous
removal of large tissue masses. In
combination with the corresponding
auxiliary instruments it can be used as
a nephroscope in the disintegration
and removal/aspiration of kidney and
bladder stones and the removal of
tumors via percutaneous (kidney) or
transurethral (bladder) passages, in
conjunction with intracorporeal 5-
4ithotripters e.g. operated
pneumatically, by ultrasound,
electrohydraulically or by laser, under
endoscopic control. The POWER
CONTROL 2303 in conjunction with
POWER STICK M4 serves to drive
WOLF morcellators for the continuous
removal of ablated tissue in | The MultiCut Solo
Morcellator is intended
for use under
endoscopic visualization
for the transurethral
mechanical morcellation
and removal of the
adenoma after
enucleation of the
prostate during
endoscopic surgical
procedures in urology. |
| | Primary Predicate
Device | Secondary Predicate
Device | Subject Device |
| | | PUMP is used for aspirating irrigation
fluid in conjunction with a
resectoscope or a morcellator
following laser TURP. | |
| Speed
Regulation | Possible from the
vacuum
generator | Possible from the vacuum
generator | Possible from the
vacuum
generator |
| External Tube
Dimension | 39.5 cm length
0.47 cm external
diameter | 35 or 38 cm length
0.475 cm external diameter | 35.0 or 40.0 cm length
0.47 cm (15 Fr) external
diameter |
| Material in
Contact with
Tissue | Stainless steel | Stainless steel | Stainless steel |
| Power Supply | AC Power Supplied | AC Power Supplied | AC Power Supplied |
| Rotation Speed | Up to 600 rpm | Up to 6000 rpm | Up to 3000 rpm |
| Aspiration | Max 1.65 l/min | Max. 1,3 l/min | Max 1.1 l/min |
| Electrical
Requirements | 100-240 V , 50/60 Hz ,
max 200 VA | 100-240 V , 50/60 Hz , max 120 VA | ~100-240 V, 50/60 Hz,
max. 90 VA |
| Suction Pump | Part of System Console | Part of System Console | Part of System Console |
| Supplied Sterile | NO | NO | NO |
| Re-Usable | YES | Provided Single or PluriUse | YES |
Summary of the technological characteristics of the new device in comparison to the predicate
6
Comparison with predicate device:
The subject and predicate devices have similar intended use and the same fundamental principles of surgical cutting and aspiration of dissected tissue. Any minor difference does not raise concern about safety and effectiveness.
Conclusions
The non-clinical performance testing conducted supports that the device can be used safely and effectively. The differences in the indications for use and technological characteristics between the subject and predicate device do not raise new types of questions regarding safety and effectiveness, and the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.