(606 days)
Reloadable Cutters
The ClearMedical Reprocessed Reloadable Cutters are intended for transection, resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery.
Reloadable Staplers
The ClearMedical Reprocessed Reloadable Staplers are intended for the resection of tissues in the alimentary tract and in thoracic surgery.
The Reprocessed Reloadable Cutters deliver two double-staggered rows of titanium staples while dividing the tissue between the rows. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.
The Reprocessed Reloadable Staplers deliver two double-staggered rows of titanium staples to approximate internal tissues. The reloadable cutters may be reloaded during a single procedure, up to a maximum number of firings per instrument as stated in the product insert.
The provided text is a 510(k) Summary for a medical device called "ClearMedical Reprocessed Reloadable Linear Cutters and Staplers" (K033579) and a subsequent FDA clearance letter for a related product with similar name (K033578). The documents essentially state that the reprocessed devices are substantially equivalent to their predicate devices. However, the text does NOT contain information about specific acceptance criteria or a detailed study proving the device meets those criteria.
The 510(k) Summary states: "Validation of cleaning, performance, packaging, and sterilization together with biocompatibility testing demonstrate reprocessed clip reloadable cutters and staplers perform as intended and are safe and effective." This is a high-level statement and does not provide the specifics requested in your prompt.
Therefore, I cannot fill out the requested table and answer the study-related questions based on the provided input because the required detailed information is not present. The document focuses on establishing substantial equivalence based on the technological characteristics being unchanged and relying on general validation of various aspects rather than a specific comparative performance study with defined acceptance criteria and statistical analysis.
If this information were present, it would typically be found in dedicated sections detailing performance testing methodologies, results, and statistical analyses, which are absent here.
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KO33579
JUL 1 ] 2005
510(k) Summary
:
| Submitter: | ClearMedical, Inc.1776 136th Place NEBellevue, WA 98005 |
|---|---|
| Contact: | Gene LimPh: (425) 460-2779Fax: (425) 401-1515 |
| Date: | June 21, 2005 |
| Trade name: | ClearMedical Reprocessed Reloadable Linear Cutters and Staplers |
| Common name: | Reloadable Linear Cutters and Linear Staplers |
| Classification name: | Manual surgical instrument for general use (21 CFR 878.4800) |
| Product code: | GCJ - Laparoscope, General & Plastic Surgery |
| Predicate device: | K020779 - Endopath and Proximate Linear Cutters and Staplers |
| Device description: | The Reprocessed Reloadable Cutters deliver two double-staggeredrows of titanium staples while dividing the tissue between therows. The reloadable cutters may be reloaded during a singleprocedure, up to a maximum number of firings per instrument asstated in the product insert.The Reprocessed Reloadable Staplers deliver two double-staggeredrows of titanium staples to approximate internal tissues. Thereloadable cutters may be reloaded during a single procedure, up toa maximum number of firings per instrument as stated in theproduct insert. |
| Intended use: | The ClearMedical Reprocessed Reloadable Cutters are intendedfor transection, resection, and creation of anastomoses ingastrointestinal, gynecologic, thoracic, and pediatric surgery.The ClearMedical Reprocessed Reloadable Staplers are intendedfor the resection of tissues in the alimentary tract and in thoracicsurgery. |
| Technologicalcharacteristics: | Reprocessed reloadable cutters and staplers are used devices thatare cleaned, inspected, tested, packaged, and sterilized for anadditional single patient use. The technological characteristics ofdesign, material, and functional performance of reprocessedreloadable cutters and staplers are unchanged and remainequivalent to the predicate devices. |
| Test data: | Validation of cleaning, performance, packaging, and sterilizationtogether with biocompatibility testing demonstrate reprocessed clipreloadable cutters and staplers perform as intended and are safeand effective. |
| Conclusion: | Based on information provided in this submission, ClearMedicalReprocessed Reloadable Cutters and Staplers are substantiallyequivalent to the identified predicate devices and are safe andeffective for their intended use. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a bird-like figure with three wing-like shapes.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2005
Clear Medical Incorporated Mr. Mike Kovacs 1776 136th Place Northeast Bellevue, Washington 98005
Re: K033578
K033578
Trade/Device Name: Reprocessed Reloadable Cutters, Staplers, and Appliers Models, Reprocessed Reloadable Cattle, Success, Success, Proximate Linear Staplers TL30, TL60, TX30B, and TX60B Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: NLL Dated: May 27, 2005 Received: May 31, 2005
Dear Mr. Kovacs:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati We have reviewed your Section 210(x) premained is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced anove and nave decimined the devices marketed predicate devices marketed in interstate for use stated in the encrosule) to regary manced provice andical Device Ameridae, or to commerce prior to May 28, 1970, the charger with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a presisions of the Act. The and Cosmetic Act (Act) that to not require approvial controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions o You may, therefore, market the device, subject or as general registration, listing of
general controls provisions of the Act include requirements for annual registration, lis general controls provisions of the Fee merator seat prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Scc above) into entrols. Existins major regulations affecting your device
it may be subject to such additional controls. Existing may on and it may be subject to such additional controll. "Entroling 21, Parts 800 to 898. In addition, FDA can be found in the Code of Federal Regardies)
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 Please be advised that FDA s issualio of a studential with other requirements of the Act
that FDA has made a determination that your device complies with on your that FDA has made a decisimilation that Jour assess of by other Federal agencies. You must of any Pederal Statutes and regulations daminities on of limited to: registration and issting (21 l comply with all the Act S requirements, mercesses on annufacturing practice requirements as set CPR Part 807), labeling (21 CFR Part 820); and If applicable, the electronic forth in the quality systems (QD) regalistics (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Mike Kovacs
This letter will allow you to begin marketing your device as described in your Section 510(k)
The are and the support of a line of a location to tiel assivelence of your devi This letter will allow you to begin maketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial equive and thus, p premarket notification. The IDA Inding of substanted organ 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
rs (11) 11 (11) 11 (11) 111 (11) 176 0115 - Alge - places note the regulat If you desire specific advice for your device on our labeling news note (
contact the Office of Compliance at (240) 276-0115 . Also, please note (2010) . You may obtain contact the Office of Compliance at (240) 270 - 1780, p. Part 807.97). You may obtain
"Misbranding by reference to premarket notification of Small "Misbranding by reference to premarket noutheadon" (1 on the Division of Small
other general information on your responsibilities under the Act from the Division of Small other general information on your responsionities and its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-free wares/cuppo Manufacturers, International and Consumer 71ssistance as tos vol. Industry/support/index.html.
Sincerely yours,
iriam C. Provost
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K033578
$
Device Name: Reprocessed Reloadable Cutters and Staplers
Indications for Use:
Reloadable Cutters
The ClearMedical Reprocessed Reloadable Cutters are intended for transection, The ClearMedical Reprocessed Reloadable Cuttors and a
resection, and creation of anastomoses in gastrointestinal, gynecologic, thoracic, and pediatric surgery.
Reloadable Staplers
The ClearMedical Reprocessed Reloadable Staplers are intended for the resection THE Cleariviculed! Represent and in thoracic surgery.
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 (
) THE SE DO NOT WRITE BELOW (FANSED) IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Device
510(k) Number K033578
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.