(90 days)
Not Found
Not Found
No
The summary describes a mechanical surgical device and its control unit, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is intended for use by surgeons during urologic laparoscopic procedures, including nephrectomy, which are therapeutic interventions.
No
The device description states its intended use is during urologic laparoscopic procedures, including nephrectomy, which are surgical procedures, not diagnostic ones.
No
The device description explicitly states it is a "motorized, reusable surgical device system" and includes a "motor drive control unit," indicating it is a hardware device with electromechanical components, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for use by surgeons during urologic laparoscopic procedures. This is a surgical device used in vivo (within the body), not in vitro (outside the body) for diagnostic purposes.
- Device Description: The description confirms it's a motorized surgical device system.
- Lack of IVD Indicators: There is no mention of analyzing samples (blood, tissue, etc.), diagnostic purposes, or any of the typical characteristics of an IVD.
IVDs are devices used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used to perform a procedure.
N/A
Intended Use / Indications for Use
These instruments are intended for use by qualified surgeons during urologic laparoscopic procedures, including nephrectomy.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The KSEA SAWAHLE Electromechanical Morcellator is a motorized, reusable surgical device system, intended for use during urologic laparoscopic procedures, including nephrectomy. The UNIDRIVE II is its motor drive control unit.
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
Not Found
Intended User / Care Setting
qualified surgeons / 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
Karl Storz Endoscopy-America, Inc. James Lee, Ph.D. Regulatory Affairs Specialist 600 Corporate Pointe, 5th Floor Culver City, CA 90230-7600
Re: K011841
Trade/Device Name: KSEA SAWAHLE Electromechanical Morcellator Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated (Date on orig SE ltr): June 11, 2001 Received (Date on orig SE ltr): June 12, 2001
Dear James Lee:
This letter corrects our substantially equivalent letter of July 27, 2015.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially (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.
1
Page 2 - James Lee, Ph.D.
You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 801); medical device reporting of medical 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/2/Picture/0 description: The image shows two clusters of black dots against a white background. The cluster on the left appears denser, with the dots more tightly packed together. The cluster on the right is less dense, with the dots more spread out. The dots are irregularly shaped and vary in size.
Image /page/2/Picture/1 description: The image shows a black and white pattern of dots. The dots are more sparse on the left side of the image and become more dense towards the right. There is a large black circle with a white center on the right side of the image.
510(k) Number (if known): Not yet assigned
Device Name: KSEA SAWAHLE Electromechanical Morcellator and Accessories
Indication for Use: These instruments are intended for use by qualified surgeons during urologic laparoscopic procedures, including nephrectorny.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) |
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Division Sign-off | |
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------------------- | -- |
Division Sign-Up
Division of Reproduction, Abdominal,
and Radiological Devices K011841
510(k) Number
Prescription Use: OR Over-The-Counter Use: (Per 21 CFR 801.109)
(Optional Format 1-2-96)
003
3
510(k) SUMMARY OF SAFETY AND EFFEC TIVENESS
This summary of 510(k) safety and effectiveness intormation is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | James A. Lee, Ph.D.
Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Tissue Morcellator |
| | Trade Name: (optional)
KSEA SAWAHLE Electromechanical Morcellator |
Indication: These instruments are intended for use by qualified surgeons during urologic laparoscopic procedures, including nephrectomy.
Device Description: The KSEA SAWAHLE Electromechanical Morcellator is a motorized, reusable surgical device system, intended for use during urologic laparoscopic procedures, including nephrectomy. The UNIDRIVE II is its motor drive control unit.
Substantial Equivalence: The KSEA SAWAHLE Electromechanical Morcellator is substantially equivalent to the predicate devices since the basic features, design and intended uses are similar. The minor differences in design and dimensions between the KSEA SAWAHLE Electromechanical Morcellator and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of these devices.
Signed:
James A. Lee, Ph.D. Regulatory Affairs Specialist
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