(32 days)
Not Found
No
The summary describes a mechanical surgical system for cutting and removing tissue, with no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
No
The device is used for surgical procedures involving cutting, removal, and shaping of tissue and bone, which are interventions rather than therapeutic treatments aimed at restoring health.
No
The 'Intended Use' section describes surgical procedures for cutting, removing, and ablating tissue, not diagnosing conditions.
No
The device description explicitly lists hardware components such as a reusable power control unit, a sterile, disposable pump cartridge and tubing assembly, and sterile, disposable handpieces.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system used for cutting, removing, ablating, and shaping tissues (soft and hard) during orthopedic surgical procedures. This is a direct intervention on the patient's body.
- Device Description: The device description details a surgical system with a power control unit, pump, tubing, and handpieces with burrs and curettes. These are tools used for physical manipulation of tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and minimally invasive spinal surgeries and small and large joint arthroscopic procedures.
Product codes
HRX
Device Description
The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces with curette. It provides the same functions as the predicate upon which it is based. The handpiece includes the rotating burr, which is driven by a fluidjet driven rotor.
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
Bench and cadaver testing were conducted to determine device functionality and conformance to design input requirements.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
HydroCision 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: 978-474-9300 Fax: 978-474- 5037
510K Summary of Safety and Effectiveness August 8, 2003 ArthroJet System with Cautery, TurboBurr, and Curette A Modification to the ArthroJet System with Cautery and TurboBurr
1. Sponsor Name
HydroCision, Inc 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: 978-474-9300 Contact Individual: Debbie lampietro
Device Name 2.
Proprietary Name: ArthroJet System with Cautery, TurboBurr, and Curette Common/Usual Name: Arthroscope and Accessories Classification name: Arthroscope and Accessories
Identification of Legally Marketed Device 3.
The modified HydroCision ArthroJet System with Cautery, TurboBurr, and Curette is substantially equivalent in intended use to the HydroCision ArthroJet System with Cautery and TurboBurr (K020688).
Device Description 4.
The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces with curette. It provides the same functions as the predicate upon which it is based. The handpiece includes the rotating burr, which is driven by a fluidjet driven rotor.
-
- Intended Use
The HydroCision ArthroJet System with Cautery, TurboBurr, and Curette is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of
- Intended Use
1
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soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and minimally invasive spinal surgeries and small and large joint arthroscopic procedures.
-
- Comparison of Technological Characteristics Both the current and modified devices:
- A. Have the same intended use
Both are intended for resection of tissue and bone in open and minimally invasive orthopedic procedures.
- B. Use the same fundamental scientific technology
- a reusable power console unit
- fluid jet technology .
- mechanical cutting using sharpened steel .
- bipolar electrocautery .
- a sterile, disposable pump cartridge, handpiece and tubing assembly ● comprised of two principal components:
- a high pressure fluid conduit with integral fluidjet nozzle .
- a low pressure collection tube. .
The differences between the proposed HydroCision ArthroJet System with Cautery, Turbo Burr and Curette and the current HydroCision ArthroJet System with Cautery and TurboBurr (K020688) are:
- Addition of Curette tool to the distal end of direct fluidjet handpieces 康
-
- Performance Testing
Bench and cadaver testing were conducted to determine device functionality and conformance to design input requirements.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, with three horizontal lines above it. The symbol is stylized and modern, representing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2003
HydroCision, Inc. c/o Ms. Debbie Iampietro ORC Consulting 7 Tiffany Hopkinton, MA 01748
Re: K032529
Trade/Device Name: HydroCision ArthroJet System with Cautery, TurboBurr and Curette Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: August 8, 2003 Received: August 21, 2003
Dear Ms. Iampietro:
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. Iisting 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 (PMA), 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 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); 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.
3
Page 2 - Ms. Debbie Iampietro
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K032529
HydroCision ArthroJet System with Cautery, TurboBurr and Curette Device Name:
Indications For Use:
The HydroCision ArthroJet System with Cautery, TurboBurr and Curette is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue and the ablation and removal of hard tissue or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation and shaping of soft tissue, and drilling, reaming, decorticating and smoothing of bone, cartilage and other bone related tissue in a variety of surgical procedures including open and minimally invasive spinal surgeries and small and large joint arthroscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use - - - -
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
K032529 510(k) Number_