(60 days)
The InDiscal Aspiration Device and Accessories are intended for aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
The InDiscal™ Aspiration Device is a sterile, single-use device that is inserted through the InDiscal™ Aspiration Introducer into the patient to aspirate tissue disc material. The device consists of a handle, coring needle with sheath, storage chamber and activation switch. The InDiscal™ Aspiration accessories include the InDiscal™ Aspiration Introducer, InDiscal™ Aspiration Plug, InDiscal™ Aspiration Cap, InDiscal™ Aspiration Sheath
This is a 510(k) summary for a medical device called the "InDiscal™ Aspiration Kit" which includes the "InDiscal™ Aspiration Device" and its accessories. This document is a premarket notification to the FDA, asserting substantial equivalence to previously cleared devices. It does not contain a study demonstrating device performance against specific acceptance criteria in a clinical setting.
Therefore, I cannot provide the information requested about acceptance criteria and a study proving the device meets them, as this type of performance data is not typically included or required in a 510(k) summary for these types of devices. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting new clinical performance data against pre-defined acceptance criteria relevant to efficacy or accuracy in the way an AI/CADe device would.
The provided document details:
- Device Name: InDiscal™ Aspiration Kit (includes various aspiration components).
- Intended Use: Aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
- Predicate Devices: Several "Nucleotome Probe" devices manufactured by Surgical Dynamics.
- Substantial Equivalence Claim: The intended use and method of tissue removal (mechanical aspiration) are substantially equivalent to the predicate Nucleotome probes.
For devices like this, acceptance criteria would typically pertain to engineering specifications, biocompatibility, sterilization, and mechanical performance (e.g., aspiration efficiency in a lab setting), rather than clinical accuracy or effectiveness studies with human readers or AI.
If this were a submission for an AI/CADe device, the requested information would be critical. However, for this traditional medical device 510(k), such a study is not presented.
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092877
5. 510(k) Summary
Submitter Information
NOV 1 7 2009
:
北
4
A. Company Name: Baylis Medical Company Inc.
B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada
C. Company Phone: (905) 602-4875; ext 252
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meghal Khakhar
F. Summary Prepared on: 09-Nov-2009
Device Identification
A. Device Trade Name: InDiscal™ Aspiration Kit
The InDiscal™ Aspiration Kit includes the InDiscal™ Aspiration Device, InDiscal™ Aspiration Introducer, InDiscal™ Aspiration Plug, InDiscal™ Aspiration Kit, InDiscal™ Aspiration Cap, InDiscal™ Aspiration Sheath
B. Device Common Name: Percutaneous Discectomy Probe
C. Classification Name: Arthroscope and Accessories, 21 CFR 888.1100
D. Device Class: Class II
E. Device Code: HRX
Identification of Predicate Device
| Device name | Manufactured by | 510(k) number |
|---|---|---|
| Nucleotome Probe (L Kit) | Surgical Dynamics | K942987 |
| Nucleotome Probe (E Kit) | Surgical Dynamics | K931109 |
| Nucleotome 3.5 mm AutomatedPercutaneous Lumbar Probe | Surgical Dynamics | K923525 |
| Nucleotome® II (Version2) TissueAspirator/Cutter | Surgical Dynamics | K914282 |
| Surgical Dynamics Nucleotome IITissue Aspirator/cutter | Surgical Dynamics | K902778 |
| 21200 Nucleotome Probe Set | Surgical Dynamics | K040919 |
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Device Description
The InDiscal™ Aspiration Device is a sterile, single-use device that is inserted through the InDiscal™ Aspiration Introducer into the patient to aspirate tissue disc material. The device consists of a handle, coring needle with sheath, storage chamber and activation switch.
The InDiscal™ Aspiration accessories include the InDiscal™ Aspiration Introducer, InDiscal™ Aspiration Plug, InDiscal™ Aspiration Cap, InDiscal™ Aspiration Sheath
Intended Use
The InDiscal Aspiration Device and Accessories are intended for aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
Substantial Equivalence
The intended use of the InDiscal™ Aspiration Device and accessories is substantially equivalent to the Nucleotome probe predicate devices. The method used to remove the tissue for InDiscal™ Aspiration Device and Nucleotome probes is mechanical aspiration.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, facing right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 1 7 2009
Baylis Medical Company, Inc. % Ms. Meghal Khakhar Manager, Regulatory and Scientific Affairs . 2645 Matheson Boulevard, East Mississauga, Ontario Canada L4W 5S4
Re: K092877
Trade/Device Name: InDiscal Aspiration Device and Accessories Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: September 9, 2009 Received: September 18, 2009
Dear Ms. Khakhar:
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, 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 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
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Page 2 - Ms. Meghal Khakhar
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K092877
Device Name: InDiscal Aspiration Device and Accessories
Indications for Use:
The InDiscal Aspiration Device and Accessories are intended for aspiration of disc material during percutaneous discectomies in the lumbar, thoracic, and cervical regions of the spine.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nichreoble for mrn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
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510(k) Number K092877
§ 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.