(58 days)
No
The description focuses on the physical components, materials, and function of an electrosurgical device and its accessories. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as being used for "APC cutting and coagulation," which directly refers to treating or correcting a medical condition.
No
The device's intended use is for "APC cutting and coagulation," which are therapeutic procedures, not diagnostic ones. The description emphasizes its role in electrosurgery and argon plasma coagulation.
No
The device description clearly details physical components (zytel shaft, ceramic tip) and their material composition and dimensions. It also describes the device's interaction with other hardware (electrosurgery systems, argon plasma coagulation devices) and physical processes (argon flow, suction, sterilization). There is no mention of software as the primary or sole component.
Based on the provided text, the ERBE APC Raspatory Handle and Tip is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "APC cutting and coagulation" in "electrosurgical patients." This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details a surgical instrument used for applying energy (argon plasma) to tissue. It talks about shafts, tips, openings for gas flow and suction, and sterilization for reuse. These are characteristics of surgical tools, not IVD devices.
- Comparison to Predicate Devices: The predicate devices are also described as electrodes and devices used for electrosurgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In summary, the ERBE APC Raspatory Handle and Tip is a surgical instrument used for electrosurgical procedures, not a device for performing tests on samples outside the body.
N/A
Intended Use / Indications for Use
The ERBE APC Raspatory Handle and Tip's intended use is for the APC cutting and coagulation. The ERBE APC Raspatory Handle and Tip is used with the ERBOTOM ICC Series Electrosurgery Systems and Argon Plasma Coagulation devices (K963189). The Beacon Laboratories Argon Beam Laparoscopic Electrode also uses argon beam for coagulation, whereas the Valleylab Curved Spatula Tip Electrode uses general electrosurgical current for cutting and coagulation. All three devices target electrosurgical patients.
Argon Plasma Cutting and Coagulation
Product codes (comma separated list FDA assigned to the subject device)
79GEI
Device Description
The ERBE APC Raspatory Handle and Tip and the two substantially equivalent devices meet the AAMI/ANSI HF-18 standard. The ERBE APC Raspatory Handle and Tip is made of a zytel shaft and a ceramic tip. Beacon Laboratories' Argon Beam Laparoscopic Electrode also uses a similar plastic shaft and a ceramic tip. The ERBE APC Raspatory Handle and Tip has a curved spatula-like configuration, which is substantially equivalent to Valleylab's Curved Spatula Tip Electrode. The Valleylab Curved Spatula Tip Electrode uses a similar plastic for the shaft, but uses a steel tip. ERBE has extensive experience in using ceramic tips for APC Applicators; ERBE APC Probes (K963189). The ERBE APC Raspatory Handle and Tip assembly's overall length is 8.5 inches. ERBE APC Raspatory Handle and Tip are two separate components that can be changed/replaced as required. The ERBE APC Raspatory Tip possesses three openings on the concave side of the palatine arch. The argon flows out of the middle opening of the raspatory tip while the side openings suction secretions and possible smoke plume.
ERBE APC Raspatory Handle and Tip is provided non-sterile and are reusable using steam sterilization, whereas the other devices are provided sterile (via Ethylene Oxide and Gamma Radiation) and are disposable. ERBE USA has conducted a sterilization validation per EN45001 to define and support the resterilization. ERBE's APC Raspatory Handle and Tip and Beacon's electrode use argon gas, whereas the Valleylab uses conventional electrosurgical current.
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
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.
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.
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
§ 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
OCT 1 4 1999
510K SUMMARY
Submitted By: ERBE-USA 2225 Northwest Parkway Suite 105 Marietta, GA 30067
Tel: 770-955-4400 Fax: 770-955-2577
August 16, 1999 Date Prepared:
Device Name: Common Name: Argon Plasma Coagulation (APC) Raspatory Handle and Tip for use with HF current ERBOTOM ICC Series Electrosurgery Systems and APC devices
ERBE APC Raspatory Handle and Tip Trade Name:
Proprietary Name: ERBE APC Raspatory Handle and Tip
Electrosurgical cutting and coagulation Classification Name: device and accessories (21CFR878.4400)
Product Code: 79GEI
Substantially Equivalent Devices:
The ERBE APC Raspatory Handle and Tip are substantially equivalent to the following legally marketed devices: Beacon Laboratories' Argon Beam Laparoscopic Electrode (K902996) and Valleylab's Curved Spatula Tip Electrode (K904560).
Intended Uses:
The ERBE APC Raspatory Handle and Tip's intended use is for the APC cutting and coagulation. The ERBE APC Raspatory Handle and Tip is used with the ERBOTOM ICC Series Electrosurgery Systems and Argon Plasma Coagulation devices (K963189). The Beacon Laboratories Argon Beam Laparoscopic Electrode also uses argon beam for coagulation, whereas the Valleylab Curved Spatula Tip Electrode uses general electrosurgical current for cutting and coagulation. All three devices target electrosurgical patients.
1
510K SUMMARY
Device Description:
The ERBE APC Raspatory Handle and Tip and the two substantially equivalent devices meet the AAMI/ANSI HF-18 standard. The ERBE APC Raspatory Handle and Tip is made of a zytel shaft and a ceramic tip. Beacon Laboratories' Argon Beam Laparoscopic Electrode also uses a similar plastic shaft and a ceramic tip. The ERBE APC Raspatory Handle and Tip has a curved spatula-like configuration, which is substantially equivalent to Valleylab's Curved Spatula Tip Electrode. The Valleylab Curved Spatula Tip Electrode uses a similar plastic for the shaft, but uses a steel tip. ERBE has extensive experience in using ceramic tips for APC Applicators; ERBE APC Probes (K963189). The ERBE APC Raspatory Handle and Tip assembly's overall length is 8.5 inches. ERBE APC Raspatory Handle and Tip are two separate components that can be changed/replaced as required. The ERBE APC Raspatory Tip possesses three openings on the concave side of the palatine arch. The argon flows out of the middle opening of the raspatory tip while the side openings suction secretions and possible smoke plume.
ERBE APC Raspatory Handle and Tip is provided non-sterile and are reusable using steam sterilization, whereas the other devices are provided sterile (via Ethylene Oxide and Gamma Radiation) and are disposable. ERBE USA has conducted a sterilization validation per EN45001 to define and support the resterilization. ERBE's APC Raspatory Handle and Tip and Beacon's electrode use argon gas, whereas the Valleylab uses conventional electrosurgical current.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1999
Mr. Scott Cundy Regulatory Affairs/Quality Assurance Manager ERBE USA, Inc. 2225 Northwest Parkway Suite 105 Marietta, Georgia 30067
K992764 Re:
Trade Name: ERBE APC Raspatory Handle and Tip Regulatory Class: II Product Code: GEI Dated: August 16, 1999 Received: August 17, 1999
Dear Mr. Cundy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Scott Cundy
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
K 99 2764
Argon Plasma Cutting and Coagulation ●
ਦੇ
(Division Sign-Off) (Division Sign-On)
Division of General Restorative Devices كم م 510(k) Number -
Prescription Use (Per 21 CFR 801.109)