(48 days)
No
The summary describes a surgical device with mechanical and electrical functions (hydro-jet and cautery) and makes no mention of AI or ML capabilities.
Yes
The device is used to resect damaged tissue and control bleeding, which are direct treatments for medical conditions.
No
The device is described as a surgical tool for resecting tissue, removing matter, and controlling bleeding, not for diagnosis.
No
The device description clearly outlines a physical surgical device with a handpiece, cauterization function, and compatibility with RF generators, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a surgical tool that provides cutting, tissue removal, and electrocauterization. These are all actions performed in vivo (within a living organism).
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health. The description and intended use of the HydroCision ArthroJet System with Cautery do not involve the analysis of specimens outside the body.
Therefore, the HydroCision ArthroJet System with Cautery is a surgical device used for direct intervention on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the HydroCision ArthroJet System with Cautery is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.
Product codes
HRX
Device Description
The HydroCision ArthroJet System with Cautery is a surgical device which provides cutting, tissue removal, and electrocauterization in the same tool. The HydroCision ArthroJet System with Cautery uses the same system as the FDA approved HydroCision ArthroJet System (K982266) with the addition of a bipolar cauterization function at the distal tip of the handpiece.
The ArthroJet System with Cautery is compatible with standard RF generators which provide bipolar energy output (with a voltage of less than or equal to 1.000 volts p-p).
The ArthroJet System with Cautery overates in a saline or Ringer's Lactate environment. These typical arthroscopic irrigation fluids are conductive and serve as a path for the electrical energy to return to the generator, as described. The hand piece and electrical connections are protected from the possibility of shorting should spillage of conductive fluid onto the unit occur.
The bipolar cables used in the ArthroJet System with Cautery are available in two types, reusable and single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
articular body cavities
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
Performance Testing
The ArthroJet System with Cautery adds a cauterization function to the original HydroCision ArthroJet System (K982266).
HydroCision Inc. ArthroJet System with Cautery complies with the following voluntary standards:
ANSI/AAMI HF18-1993 IEC 60601-2
Key Metrics
Not Found
Predicate Device(s)
K982266, K861112, K791638, K965421
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
OCT 2 5 1999
HYDROCISION, INC. 220 Ballardvale Street Wilmington, MA 01887 (978) 657- 0020
510K Summary
Sponsor Name HydroCision, Inc. 220 Ballardvale Street Willmington, MA 01887 978 657 0020
- Device Name
Proprietary Name: HydroCision ArthroJet System with Cautery Common/Usual Name: Arthroscope and accessories Electrosurgical Cutting and Coagulation Device and Accessories Classification Name: Arthroscope and accessories Electrosurgical Cutting and Coagulation Device and Accessories
- Identification of Predicate or Legally Marketed Device 3. The HydroCision ArthroJet System with Cautery substantially equivalent in intended use and/or function to the following predicate devices: the HydroCision ArthroJet System (K982266) and the Valleylab Electrosurgical Pencil (K861112)/Valleylab Electrode (K791638), and the Kirwan Suction Coagulator (K965421). It is also substantially equivalent to the ArthroCare Electrosurgery System (K961323) in that the ArthroCare unit provides all the above functions in the same unit and handpiece.
4. Device Description
The HydroCision ArthroJet System with Cautery is a surgical device which provides cutting, tissue removal, and electrocauterization in the same tool. The HydroCision ArthroJet System with Cautery uses the same system as the FDA approved HydroCision ArthroJet System (K982266) with the addition of a bipolar cauterization function at the distal tip of the handpiece.
The ArthroJet System with Cautery is compatible with standard RF generators which provide bipolar energy output (with a voltage of less than or equal to 1.000 volts p-p).
HydroCision Arthrojet System with Cautery 510K Summary Page 1 of 3
1
HYDROCISION, INC. 220 Ballardvale Street Wilmington, MA 01887 (978) 657- 0020
The ArthroJet System with Cautery overates in a saline or Ringer's Lactate environment. These typical arthroscopic irrigation fluids are conductive and serve as a path for the electrical energy to return to the generator, as described. The hand piece and electrical connections are protected from the possibility of shorting should spillage of conductive fluid onto the unit occur.
The bipolar cables used in the ArthroJet System with Cautery are available in two types, reusable and single use.
Intended Use న్.
The intended use of the HydroCision ArthroJet System with Cauterv is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.
6. Comparison of Technological Characteristics
The HydroCision ArthroJet System with Cautery is a surgical device which provides cutting, tissue removal, and electrocauterization in the same tool. It is substantially equivalent in intended use and/or function to the following predicate devices: the HydroCision ArthroJet System (K982266), the Valleylab Electrosurgical Pencil (K861112)/Valleylab Electrode (K791638), and the Kirwan Suction Coagulator (K965421). It is also substantially equivalent to the ArthroCare Electrosurgery System (K963123) in that the ArthroCare unit provides all the above functions in the same unit and handpiece.
The HydroCision ArthroJet System with Cautery provides the same functions as the first predicate device, the HydroCision ArthroJet System (K982266). Both are used in arthroscopy to cut and remove tissues. They are the same device, with the exception that the HydroCision ArthroJet System with Cautery provides the additional electrocautery function using bipolar energy to cauterize small vessels that ooze during surgery. The electrocautery function and its intended use is the same as that provided by the Valleylab Electrosurgical Pencil (K861112)/Electrode (K791638) and the Kirwan Suction Coagulator (K965421).
HydroCision Arthrojet System with Cautery 510K Summary Page 2 of 3
2
HYDROCISION, INC. 220 Ballardvale Street Wilmington, MA 01887 (978) 657- 0020
The mechanical action of the ArthroCare Electrosurgery System is different but it has been included as a predicate device to demonstrate the basis for a multiple function handpiece used for arthroscopic and general surgery.
-
- Performance Testing
The ArthroJet System with Cautery adds a cauterization function to the original HydroCision ArthroJet System (K982266).
- Performance Testing
HydroCision Inc. ArthroJet System with Cautery complies with the following voluntary standards:
ANSI/AAMI HF18-1993 IEC 60601-2
HydroCision Arthrojet System with Cautery 510K Summary Page 3 of 3
00063
3
Image /page/3/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of three wavy lines, resembling a symbol or logo. The overall design is simple and official-looking.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 25 1999
Ms. Debbie Iampietro Consultant HydroCision, Inc. 220 Ballardvale Street Wilmington, Massachusetts 01887
Re: K993009 Trade Name: HydroCision ArthoJet System with Cautery Regulatory Class: II Product Code: HRX Dated: August 31, 1999 Received: September 7, 1999
Dear Ms. Iampietro:
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.
4
Page 2 - Ms. Debbie Iampietro
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,
Calix M. Witter, Ph.D., M.D.
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
5
510(k) Number (if known): K993009
HydroCision ArthroJet System with Cautery Device Name:
Indications For Use:
The intended use of the HydroCision ArthroJet System with Cautery is to resect damaged tissue, remove extraneous matter, and control bleeding in surgical applications of articular body cavities.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K993009 | 000010 |
|---|---|---|
| --------------- | --------- | -------- |