(30 days)
The HydroCision ArthroJet System with Cautery and TurboBurr 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 arthroscopic spinal surgeries and small and large joint arthroscopic procedures.
The HydroCision ArthroJet System with Cautery and TurboBurr consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces. 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.
The provided text describes a 510(k) submission for a medical device modification, the HydroCision ArthroJet System with Cautery and TurboBurr. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria against quantitative performance metrics for a novel efficacy claim.
Therefore, many of the specific questions about acceptance criteria, detailed study design, sample sizes, expert ground truth, and comparative effectiveness studies cannot be fully answered from the given document as they are not explicitly reported in this type of submission.
However, based on the information provided, here's a breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria or detailed results of device performance against such criteria. The "Performance Testing" section states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functionality as per design input requirements | Bench and cadaver testing confirmed "device functionality" |
| Conformance to design input requirements | Bench and cadaver testing confirmed "conformance to design input requirements" |
| Substantial equivalence to predicate device (K002764 and K011444) | FDA determined the device is "substantially equivalent" |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Bench and cadaver testing," but no numbers are provided for how many tests were performed or how many cadavers were used.
- Data Provenance: The document does not specify the country of origin. The testing appears to be prospective bench and cadaver testing conducted by the manufacturer, HydroCision, Inc.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not stated. The document doesn't describe the establishment of a "ground truth" by experts in the context of clinical outcomes or diagnostic accuracy. The testing performed was for device functionality and design conformance.
4. Adjudication Method for the Test Set
Not applicable/Not stated. No adjudication method is described as the testing performed was focused on engineering and functional validation rather than clinical assessment requiring expert consensus.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated. This type of study is more common for diagnostic imaging devices where human reader performance is a key metric. The submission focuses on device function and substantial equivalence for a surgical tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical tool, not an algorithm. The testing described would inherently involve human operators, even in a bench setting.
7. The Type of Ground Truth Used
The "ground truth" in this context appears to be engineering specifications and functional requirements for the device. The testing aimed to confirm that the device performs its intended functions (cutting, ablation, drilling, etc.) and meets its design inputs. There's no mention of pathology, expert consensus on clinical findings, or long-term outcomes data for establishing ground truth in this submission.
8. The Sample Size for the Training Set
Not applicable/Not stated. There is no mention of a "training set" in the context of this device. Training sets are typically associated with machine learning algorithms, which are not described here.
9. How the Ground Truth for the Training Set was Established
Not applicable. As no training set is mentioned, the method for establishing its ground truth is also not applicable.
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K020688 1/2
APR 0 3 2002
HydroCision 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: 978-474-9300 Fax: 978-474- 5037
510K Summary of Safety and Effectiveness February 27, 2002 HydroCision ArthroJet System with Cautery and TurboBurr A Modification to the HydroCision ArthroJet System with Cautery and Burr
- Sponsor Name 1.
HydroCision, Inc 100 Burtt Rd. Suite G01 Andover, MA 01810 Tel: 978-474-9300 Contact Individual: Debbie Iampietro
2. Device Name
Proprietary Name: HydroCision ArthroJet System with Cautery and TurboBurr Common/Usual Name: Arthroscope and Accessories Classification name: Arthroscope and Accessories
4. Device Description
The HydroCision ArthroJet System with Cautery and TurboBurr consists of the reusable power control unit; a sterile, disposable pump cartridge and tubing assembly; and sterile, disposable handpieces. 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.
- ડ. Intended Use
The HydroCision ArthroJet System with Cautery and TurboBurr 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,
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K020688 2/2
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 arthroscopic spinal surgeries and small and large joint arthroscopic procedures.
- Comparison of Technological Characteristics 6. Both the current and modified devices:
- Have the same indicated use A. Both are intended for resection of tissue and bone in open and arthroscopic spinal surgeries and small and large joint arthroscopic procedures.
- Use the same fundamental scientific technology B.
- a reusable power console unit .
- fluid jet technology .
- a sterile, disposable pump cartridge and tubing assembly, and . handpiece assemblies 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 C. Cautery and TurboBurr and the current HydroCision ArthroJet System with Cautery and Burr (K002764) are:
- Direct fluidjet functions have been separated from the rotational o functions into a variety of handpieces with slightly different tip configurations. This allows the handpieces of the modified device to be smaller than the current device, which combines direct fluidjet and rotational functions. It also allows the surgeon to select from a variety of different tip geometries to optimize access to the target tissue.
- The attachment of the handpiece to the pump cartridge and tubing o assembly has been changed from a permanently affixed attachment to a quick disconnect. This allows the surgeon to easily change handpieces for different functions and optimized access to target tissue.
- The turbine drive mechanism for the burr is being modified from o gear driven to direct drive, resulting in higher rotational speed of the tip and lower torque.
-
- Performance Testing
Bench and cadaver testing were conducted to determine device functionality and conformance to design input requirements.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle or bird-like figure with three wing-like lines extending upwards and to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hydrocision, Inc. c/o Ms. Debbie Iampietro QRC Consulting, Inc. 7 Tiffany Trail Hopkinton, MA 01748
APR 0 3 2002
Re: K020688
Trade/Device Name: HydroCision ArthroJet System with Cautery and TurboBurr Regulation Number: 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: February 27, 2002 Received: March 4, 2002
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 for ass sured in the encrease 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.
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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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
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5 10(k) Number (if known):
Device Name:
HydroCision ArthroJet System with Cautery and TurboBurr
Indications For Use:
The HydroCision ArthroJet System with Cautery and TurboBurr 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 arthroscopic 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
Muriam C. Provost
eral Restorative and Neurological D
510(k) Number K020658
§ 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.