(274 days)
No
The summary describes mechanical hand instruments for endoscopic procedures and does not mention any AI or ML components or functionalities.
No.
The device is described as a hand instrument for endoscopic diagnosis and treatment (grasping, dissection, biopsy, cutting), which are surgical functions, not therapeutic in nature. The term "treatment" in this context refers to the practical execution of a surgical procedure, not the application of a therapy.
No
The device is described as being used for "endoscopic diagnosis and treatment," and its functions include "grasping, dissection, biopsy and cutting." While diagnosis is mentioned, the core function described (grasping, cutting, biopsy) are typically interventional or for sample collection, not for generating or interpreting diagnostic information. The emphasis is on instrumental procedures for treatment or obtaining samples, rather than providing a diagnosis itself.
No
The device description explicitly states it is a completely assembled finished device including physical components like jaws, shafts, and handles, and mentions mechanical and functional performance testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the instruments are for "endoscopic diagnosis and treatment during the thoracoscopic and laparoscopic procedures within the peritoneal and thoracic cavity." This describes a surgical/interventional procedure performed directly on the patient's body.
- Device Description: The description details instruments used for "grasping, dissection, biopsy and cutting (scissors) under endoscopic visualization." These are all actions performed in vivo (within the living body).
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, tissue, or urine) in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens outside the body.
The device is a surgical instrument used for procedures within the body, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The Olympus hand instruments are specifically designed for endoscopic diagnosis and treatment during the thoracoscopic and laparoscopic procedures within the peritoneal and thoracic cavity.
Product codes
GEI, GCJ
Device Description
The Olympus HICURA hand instruments are used for grasping, dissection, biopsy and cutting (scissors) under endoscopic visualization. Depending on their design every single jaw insert can be used for various applications. The variety of the iaw inserts, handles and shafts is defined by the different lengths of the instruments, handles styles and a large variety of jaw inserts. The Olympus HICURA hand instruments will be marketed as a completely assembled finished device which includes jaws with control rod, insulated rotatable shaft, and handle. Individual components such as jaws with control rod, insulated shaft, or handle will be available separately as modular components.
The HICURA hand instruments use a modular design in which each instrument can be disassembled into the following three pieces:
-
- Handle
-
- Outer Shaft/Insulation
-
- Jaw insert with control rod
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal and thoracic cavity
Indicated Patient Age Range
Not Found
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)
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Basic safety and performance testing was performed in accordance with international approved technical standards such as IEC 60601 (see list below).
Additional testing was conducted to evaluate the mechanical and functional performance including g tensile strength, g bending strenath. assembly/disassembly, grasping force, shaft rotation, dielectical strength, electrical resistance, leakage current, transport and storage conditions, reprocessing and usability (erqonomics, assembly/disassembly, shaft rotation, color coding, overall design confidence).
Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996."
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, featuring three human profiles facing right, suggesting a sense of community and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 10, 2014
Olympus Winter and Ibe GmbH % Ms. Sheri Musgnung Olympus Corporation of the Americas 3500 Corporate Parkway Center Valley, Pennsylvania 18034
Re: K140624
Trade/Device Name: HICURA Hand Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 7, 2014 Received: November 10, 2014
Dear Ms. Musgnung:
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
1
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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140624
Device Name HICURA Hand Instruments
Indications for Use (Describe)
The Olympus hand instruments are specifically designed for endoscopic diagnosis and treatment during the thoracoscopic and laparoscopic procedures within the peritoneal and thoracic cavity.
| 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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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary of Safety and Effectiveness
1. General information
I
| • Applicant: | Olympus Winter & Ibe GmbH |
|---|---|
| Kuehnstr. 61 | |
| 22045 Hamburg | |
| Germany |
-
Official Correspondent: Sheri L. Musanuna Regulatory Affairs & Quality Assurance Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, PA 18034-0610 Phone: 484-896-3147 FAX: 484-896-7128 Email: sheri.musgnung@olympus.com Establishment Registration No.: 2429304
Germany -
Manufacturer: Olympus Winter & Ibe GmbH Kuehnstr. 61 22045 Hamburg
-
I Registration number: 9610773
-
Contact person:
Mr. Holger Nadler Phone: +49-66966-2144 +49-66966-2134 Fax: Email: holger.nadler@olympus-oste.eu
- Prepared Date: December 9, 2014
2. Device identification
트
- 트 Proprietary name:
- Common name:
- . Classification name:
- Regulations Number:
- 트 Regulatory class:
- . Product code:
- 트 Device panel:
)
HICURA Hand instruments Hand instruments Electrosurgical cutting and coagulation and accessories, Endoscope and Accessories 21 CFR 878.4400 / 21 CFR 876.1500
Class II GEI, GCJ General & Plastic Surgery
4
3. Predicate devices
K944200 / K944201; K984417 Olympus HiQ Hand Instruments; Bipolar Grasping Forceps BiQ+
4. Description of device
The Olympus hand instruments are specifically designed for endoscopic diagnosis and treatment during the thoracoscopic and laparoscopic procedures within the peritoneal and thoracic cavities.
The Olympus HICURA hand instruments are used for grasping, dissection, biopsy and cutting (scissors) under endoscopic visualization. Depending on their design every single jaw insert can be used for various applications. The variety of the iaw inserts, handles and shafts is defined by the different lengths of the instruments, handles styles and a large variety of jaw inserts. The Olympus HICURA hand instruments will be marketed as a completely assembled finished device which includes jaws with control rod, insulated rotatable shaft, and handle. Individual components such as jaws with control rod, insulated shaft, or handle will be available separately as modular components.
The HICURA hand instruments use a modular design in which each instrument can be disassembled into the following three pieces:
-
- Handle
-
- Outer Shaft/Insulation
-
- Jaw insert with control rod
5. Indications of use
The Olympus hand instruments are specifically designed for endoscopic diagnosis and treatment during the thoracoscopic and laparoscopic procedures within the peritoneal and thoracic cavities.
6. Comparison of Technological characteristics
The HICURA hand instruments share virtually all specifications and design characteristics of the predicate devices. The HICURA hand instruments and predicate devices are HF-surgical instruments intended for grasping, dissection, biopsy, and cutting under endoscopic visualization. The HICURA hand instruments are easier to assemble/disassemble and more convenient in terms of ergonomics, thus have improved usability over the predicate devices.
7. Performance Testing
Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO-14971:2007.
5
Performance tests were carried out to ensure that the system functions as intended and meets design specifications. The following performance tests and usability studies were conducted:
Basic safety and performance testing was performed in accordance with international approved technical standards such as IEC 60601 (see list below).
Additional testing was conducted to evaluate the mechanical and functional performance including g tensile strength, g bending strenath. assembly/disassembly, grasping force, shaft rotation, dielectical strength, electrical resistance, leakage current, transport and storage conditions, reprocessing and usability (erqonomics, assembly/disassembly, shaft rotation, color coding, overall design confidence).
Reprocessing validation was carried out in accordance with "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance - April 1996."
The following standards have been applied to the HICURA hand instruments:
| DIN EN ISO 14971:2007 | [Recognition Number 5-40] |
|---|---|
| EN ISO 10993-1: 2009 | [Recognition Number 2-156] |
| IEC 60601-1:2005; 3rd Ed. | [Recognition Number 5-77] |
| IEC 60601-2-2:2009; 3rd Ed. | [Recognition Number 6-228] |
| AAMI/ANSI/IEC 60601-2-2:2009 | [Recognition Number 6-229] |
| IEC 60601-2-18:2009; 3rd Ed. | [Recognition Number 9-61] |
| IEC 60601-2-18 (1996) Amend 1 2000 | [Recognition Number 9-42] |
| IEC 62366: 2007 | [Recognition Number 5-67] |
| ISO 8600-1:2005 | [Recognition Number 9-37] |
| ISO 8600-1:2013 | [Recognition Number 9-83] |
8. Sterilization
HICURA hand instruments are provided non-sterile. They are reusable and need to be reprocessed before first and each subsequent use. HICURA hand instruments have to be reprocessed according to the validated procedures described in the instruction for use.
9. Biocompatibility
Biocompatibility of HICURA hand instruments has been evaluated according to the relevant parts of the AAMI ANSI ISO 10993 series for limited contact duration.
10 Conclusion
In summary, we believe the HICURA hand instruments are substantially equivalent with the predicate devices with respect to the general design approach, function, and the indications for use. The HICURA hand instruments raise no new concerns of safety or efficacy when compared to the predicate devices.