(88 days)
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Not Found
No
The device description focuses on a mechanical system using pressurized saline for tissue resection. There is no mention of AI, ML, or any related concepts in the provided text.
No
The device is used to resect damaged tissue and remove extraneous matter, which is an interventional procedure, not a therapeutic treatment.
No
Explanation: The device is described as a surgical tool used to resect tissue and remove matter from body cavities, which is a therapeutic function, not a diagnostic one. It focuses on treating damaged tissue rather than identifying or characterizing a medical condition.
No
The device description explicitly details hardware components including an electric motor, console, drive train, cartridge, tubing, and handpiece, which are integral to the device's function.
Based on the provided information, the ArthroJet system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used to "resect damaged tissue and remove extraneous matter found in articular body cavities." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a system that uses a high-pressure waterjet to cut and ablate tissue in situ. This is a therapeutic/surgical device, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ArthroJet system performs a physical action (tissue resection and removal) directly within the body.
N/A
Intended Use / Indications for Use
The ArthroJet system is intended to resect damaged tissue and remove extraneous matter found in articular body cavities. The system may be used open or arthroscopically to resect tears and other defects, remove loose fragments, shave away debris and perform appropriate synovectomy procedures.
Product codes (comma separated list FDA assigned to the subject device)
HRX
Device Description
The HydroCision ArthroJet system consists of an electric motor used to power a drive train inside a console. The drive train converts the rotational motion of a cam to a transverse motion of a plunger which in turn drives a piston contained in a disposable cartridge. The repeated motion of the piston pressurizes saline in the cartridge which is then carried through tubing to a handpiece. The handpiece delivers the high pressure saline to the joint, resulting in the cutting action of the waterjet. The result is a thin waterjet stream capable of cutting and ablating tissue which is then removed from the surgical site.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
articular body cavities
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data is provided in support of the substantial equivalence determination:
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- Porcine Evaluation: The ability of the ArthroJet to resect and ablate variuos types of tissue was demonstrated in a porcine knee.
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- In-Vivo Testing: The testing demonstrated the efficacy of the HydroCision ArthroJet in resecting rabbit menisci when compared to the predicate device. The testing confirmed that the device functions adequately to meet its intended use.
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- Bending Strength: The bending strength of the handpiece was evaluated for its ability to withstand arthroscopic applications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
SEP 2 5 1998
510(K) SUMMARY
大982266
1. SUBMITTER:
SEP 2 5 1998
HydroCision, Inc. 220 Ballardvale Street Wilmington, MA 01887 Telephone: 978-657-0020
Contact: Don Freeman, President Date Prepared: June 17, 1998
2. DEVICE:
Arthroscopic Cutting System Classification Name: Arthroscope and Accessories Trade Name: HydroCision ArthroJet
3. PREDICATE DEVICE:
The predicate device used to determine substantial equivalence for the HydroCision ArthroJet was the Dyonics Articular Shaver System, marketed by Smith & Nephew Dyonics, Andover, MA
4. DEVICE DESCRIPTION:
The HydroCision ArthroJet system consists of an electric motor used to power a drive train inside a console. The drive train converts the rotational motion of a cam to a transverse motion of a plunger which in turn drives a piston contained in a disposable cartridge. The repeated motion of the piston pressurizes saline in the cartridge which is then carried through tubing to a handpiece. The handpiece delivers the high pressure saline to the joint, resulting in the cutting action of the waterjet. The result is a thin waterjet stream capable of cutting and ablating tissue which is then removed from the surgical site.
5. INTENDED USE:
The Arthrojet system is intended to resect damaged tissue and remove extraneous matter found in articular body cavities. The system may be used open or arthroscopically to resect tears and other defects, remove loose fragments, shave away debris and perform appropriate synovectomy procedures.
1
6. COMPARISON OF CHARACTERISTICS:
The HydroCision ArthroJet system is electrically powered and consists of a console unit, pump cartridge, tubing and handpiece. It uses a drive train to pressurize saline in a pump cartridge which is delivered to a hand piece resulting in a thin high pressure waterjet stream capable of cutting and ablating tissue, which is then removed from the site.
The Dyonics shaver is also an electrically powered unit which is used to power a hand held motor. The motor is used to exert rotational force to a disposable cutter. The cutter resects tissue by rotating at high rates of speed resulting in the tissue being cut and removed from the area.
The indications for use of the two devices are identical.
7. PERFORMANCE DATA:
The following performance data is provided in support of the substantial equivalence determination:
-
- Porcine Evaluation: The ability of the ArthroJet to resect and ablate variuos types of tissue was demonstrated in a porcine knee.
-
- In-Vivo Testing: The testing demonstrated the efficacy of the HydroCision ArthroJet in resecting rabbit menisci when compared to the predicate device. The testing confirmed that the device functions adequately to meet its intended use.
-
- Bending Strength: The bending strength of the handpiece was evaluated for its ability to withstand arthroscopic applications.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
P 25 1998
D.C. Freeman, Jr. Ph.D. President HydroCision, Inc. 220 Ballardvale Street Wilmington, Massachusetts 01887
Re: K982266 Trade Name: HydroCision Arthrojet System Regulatory Class: II Product Code: HRX Dated: June 25, 1998 Received: June 29, 1998
Dear Dr. Freeman:
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, Druq, 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. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (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.
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Page 2 - Dr. Freeman, Jr.
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 your 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) 594-4659. 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
982266
INDICATION FOR USE
The ArthroJet system is intended to resect damaged tissue and remove extraneous matter found in articular body cavities. The system may be used open or arthroscopically to resect tears and other defects, remove loose fragments, shave away debris and perform appropriate synovectomy procedures.
Prescription Use
(Per 21 CFR 801.109)
法
(Divis