DIGICAP

{0}------------------------------------------------ DEC 1 9 2001 K012199 ## XII. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVENESS. Sept. 10, 1996. [Separate Pages] I.* Submitter: Dr. Syed Rizvi, Humana USA, Inc., Reno, Nevada. Ph: 661-761-9771. II. Classification Names and Numbers: Accessory to surgeon's gloves, KGO. III. Common/Usual Name: Accessory to Surgeon's gloves. IV. Proprietary Names: DigiCAP™ V. Establishment Registration Number: In progress VI. Classification: Surgeon's gloves were classified by the General and Plastic Surgery Panel under CFR 878.4460 and are Class I, restricted. VII. Substantial Equivalence: The DigiCap™ is an accessory to surgeon's gloves, Code HGO, VII. Substantial Equivalent to the many surgeon's gloves cleared under the 510(k) process and is most similar to the "Gimbel Puncture Resistant Powder Free Surgical Glove cleared under K003063. It is also similar to the Percuguard cleared under K992539 but differs from it in that the It is also similar to the receard enceramination glove during injection and examination I credgand 13 milended for ass mand for use by surgeons during various surgical procedures. The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below: 1. These products have the same intended use, to provide protection of the patient and surgeon 1. These produces have needle-sticks and scalpel cuts during surgical procedures. Both provide a tough, repellant surface to protect the fingers of surgical personnel. Since the Dour provide a tooging top of the glove, it also protects the integrity of the glove to body fluids. 2. The technological characteristics for this product are similar to those for the predicate devices and similar products currently on the market. This product, however, is made from a and - smillians presin and is of a rigid configuration whereas surgeons gloves are usually prepared from latex or vinyl materials. All materials are tested for biocompatibility. 3. Descriptive information provided shows that the materials from which the DigiCAP is made provide the protection claimed and are substantially equivalent in safety and effectiveness to those of similar products, used for similar purposes, currently on the market. 4. The FDA "Decision-Making Process" chart was also used and appears in Attachment V. [End of Summary] {1}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 1 9 2001 Humana USA, Incorporated C/O Dr. H.N. Dunning Dr. H.N. Dunning 8309 Bryant Drive Bethesda, Maryland 20817 Re: K012199 Trade/Device Name: Digicap Regulation Number: 878.4460 Regulation Name: Needle Accessory Regulatory Class: I Product Code: KGO Dated: October 30, 2001 Received: November 5, 2001 Dear Dr. Dunning: 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 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. {2}------------------------------------------------ #### Page 2 - Dr. Dunning 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. This letter will allow you to begin marketing your device as described in your Section 11ms letter will and in your of 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 11 you distre up 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 the riot may of stance 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, Timothy A. Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ### VIII.1 Indications for Use: [Separate Page] # 510(k) Number: KO) 2199 #### Device Name: DigiCAP™ DigiCap™ is a protective finger guard accessory to the surgeon's glove. 1. Intended to provide needlestick and suture/scalpel protection during a variety of surgical procedures. DigiCap™ is a protective finger guard accessory to the surgeon's glove. It is used on the finger or thumb of the non-dominant hand usually used to retract, stabilize, compress, and position tissue during surgical procedures. 2. Facilitate suture handling and placement. ### (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***_***_ (Optional format 1-2-96) Qun S. Lim 3R (Division Sign-Off) Division of Dental, Infection Control, and General Hospital De ! | Olik) Number