INDISCAL ASPIRATION DEVICE AND ACCESSORIES

K092877 · Baylis Medical Co., Inc. · HRX · Nov 17, 2009 · Orthopedic

Device Facts

Record IDK092877
Device NameINDISCAL ASPIRATION DEVICE AND ACCESSORIES
ApplicantBaylis Medical Co., Inc.
Product CodeHRX · Orthopedic
Decision DateNov 17, 2009
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.1100
Device ClassClass 2
AttributesTherapeutic

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.

Device Story

InDiscal Aspiration Device is a sterile, single-use instrument for mechanical aspiration of disc material during percutaneous discectomies. System components include handle, coring needle with sheath, storage chamber, and activation switch; accessories include introducer, plug, cap, and sheath. Device is inserted through introducer into patient spine; physician operates device to aspirate tissue. Mechanical aspiration principle removes disc material. Intended for use in lumbar, thoracic, and cervical spine regions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Sterile, single-use mechanical aspiration device. Components: handle, coring needle, sheath, storage chamber, activation switch. Accessories: introducer, plug, cap, sheath. Operates via mechanical aspiration principle.

Indications for Use

Indicated for patients undergoing percutaneous discectomy procedures in the lumbar, thoracic, or cervical spine regions for the aspiration of disc material.

Regulatory Classification

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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 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 Automated<br>Percutaneous Lumbar Probe | Surgical Dynamics | K923525 | | Nucleotome® II (Version2) Tissue<br>Aspirator/Cutter | Surgical Dynamics | K914282 | | Surgical Dynamics Nucleotome II<br>Tissue Aspirator/cutter | Surgical Dynamics | K902778 | | 21200 Nucleotome Probe Set | Surgical Dynamics | K040919 | {1}------------------------------------------------ ## 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. P. 2 of 2 {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 {4}------------------------------------------------ ## 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 Page 1 of _ 1 _ _ _ _ 510(k) Number K092877
Innolitics
510(k) Summary
Decision Summary
Classification Order
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